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Kansas University DHA Outcome Study (KUDOS) Follow-Up

Sponsor
Susan Carlson, PhD (Other)
Overall Status
Completed
CT.gov ID
NCT02487771
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
190
Enrollment
1
Location
2
Arms
94
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a continuation study to KUDOS (NCT00266825). The purpose of this study is to follow-up with participants on the original study to determine if the effects of increasing DHA intake during pregnancy increase cognitive development in 2 to 6 year-old children.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Numerous trials show benefits of postnatal DHA supplementation for visual acuity. There are also numerous observational(not intervention)studies that link higher maternal DHA status during pregnancy to higher cognitive function. Intervention studies that increase DHA exposure during fetal life and that measure cognitive development of infants are lacking; and no study to date has systematically followed children whose mothers were randomly assigned to DHA supplementation to school age with regular 6 month assessments of age-appropriate assessments of cognitive development. The absence of such studies is a serious limitation because there is evidence that differences in cognitive function due to such interventions do not become robust until around age 4 years. Women in the US consume low amounts of DHA compared to other world populations, and this likely means less DHA transfer to the fetus than in many other populations. Prenatal DHA exposure may be more important than postnatal exposure, because animal studies show critical windows for brain DHA accumulation in relation to effects on neurotransmitters such as serotonin, dopamine and GABA.

Study Design

Study Type:
Interventional
Actual Enrollment :
190 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Kansas University DHA Outcome Study (KUDOS) Follow-Up
Study Start Date :
Jul 1, 2008
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo Capsule

Drug: Placebo Capsule
600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
Experimental: DHA Capsule

Drug: DHA
600 mg DHA capsule
Other Names:
  • docosahexaenoic acid

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    Outcome Measures

    Primary Outcome Measures

    1. Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ [36 Months]

      The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15.

    2. Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ [48 Months]

      The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15.

    3. Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ [72 Months]

      The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15.

    4. Cognitive Function Score - Peabody Picture Vocabulary Test [60 Months]

      The Peabody Picture Vocabulary Test, 3rd Edition provides a standardized assessment of a person's receptive vocabulary. The Standard Score can range from 40 (poorest performance) to 160 (best performance) and has been normed to a Mean = 100, St Dev = 15.

    5. Cognitive Function Score - Test of Preschool Early Literacy [42 Months]

      The Test of Preschool Early Literacy provides a standardized Early Literacy Index score, a measure of general, early literacy skills that relate to later reading and writing skill acquisition. The score is based on assessments of vocabulary, print knowledge, and phonological awareness. The score can range from 40 (poorest performance) to 144 (best performance) and has been normed to a Mean = 100, St Dev = 15.

    6. Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ [36 Months]

      The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15.

    7. Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ [48 Months]

      The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15.

    8. Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ [72 Months]

      The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15.

    Secondary Outcome Measures

    1. Adaptive Regulation Assessment [36 Months]

      The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.

    2. Adaptive Regulation Assessment [48 Months]

      The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.

    3. Adaptive Regulation Assessment [60 Months]

      The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.

    4. Adaptive Regulation Assessment [72 Months]

      The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.

    Other Outcome Measures

    1. Anthropometrics: Weight-for-age [2 years]

      Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).

    2. Anthropometrics: Weight-for-age [2.5 years]

      Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).

    3. Anthropometrics: Weight-for-age [3 years]

      Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).

    4. Anthropometrics: Height-for-Age [2 years]

      Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.

    5. Anthropometrics: Weight-for-age [3.5 years]

      Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).

    6. Anthropometrics: Weight-for-age [4 years]

      Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).

    7. Anthropometrics: Weight-for-age [4.5 years]

      Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).

    8. Anthropometrics: Weight-for-age [5 years]

      Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).

    9. Anthropometrics: Weight-for-age [5.5 years]

      Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).

    10. Anthropometrics: Weight-for-age [6 years]

      Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).

    11. Anthropometrics: Height-for-Age [2.5 years]

      Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.

    12. Anthropometrics: Height-for-Age [3 years]

      Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.

    13. Anthropometrics: Height-for-Age [3.5 years]

      Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.

    14. Anthropometrics: Height-for-Age [4 years]

      Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.

    15. Anthropometrics: Height-for-Age [4.5 years]

      Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.

    16. Anthropometrics: Height-for-Age [5 years]

      Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.

    17. Anthropometrics: Height-for-Age [5.5 years]

      Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.

    18. Anthropometrics: Height-for-Age [6 years]

      Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.

    19. Anthropometrics: Body Mass Index-for-age [2 years]

      Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.

    20. Anthropometrics: Body Mass Index-for-age [2.5 years]

      Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.

    21. Anthropometrics: Body Mass Index-for-age [3 years]

      Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.

    22. Anthropometrics: Body Mass Index-for-age [3.5 years]

      Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.

    23. Anthropometrics: Body Mass Index-for-age [4 years]

      Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.

    24. Anthropometrics: Body Mass Index-for-age [4.5 years]

      Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.

    25. Anthropometrics: Body Mass Index-for-age [5 years]

      Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.

    26. Anthropometrics: Body Mass Index-for-age [5.5 years]

      Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.

    27. Anthropometrics: Body Mass Index-for-age [6 years]

      Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.

    28. Anthropometrics: Head Circumference-for-age [2 years]

      Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.

    29. Anthropometrics: Head Circumference-for-age [2.5 years]

      Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.

    30. Anthropometrics: Head Circumference-for-age [3 years]

      Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.

    31. Anthropometrics: Head Circumference-for-age [3.5 years]

      Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.

    32. Anthropometrics: Head Circumference-for-age [4 years]

      Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.

    33. Anthropometrics: Head Circumference-for-age [4.5 years]

      Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.

    34. Anthropometrics: Head Circumference-for-age [5 years]

      Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.

    35. Anthropometrics: Head Circumference-for-age [5.5 years]

      Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.

    36. Anthropometrics: Head Circumference-for-age [6 years]

      Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.

    37. Dietary Intake [2 years]

      Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.

    38. Dietary Intake [2.5 years]

      Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.

    39. Dietary Intake [3 years]

      Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.

    40. Dietary Intake [3.5 years]

      Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.

    41. Dietary Intake [4 years]

      Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.

    42. Dietary Intake [4.5 years]

      Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.

    43. Dietary Intake [5 years]

      Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.

    44. Dietary Intake [5.5 years]

      Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.

    45. Dietary Intake [6 years]

      Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.

    46. Systolic Blood Pressure [4 years]

      Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.

    47. Systolic Blood Pressure [4.5 years]

      Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.

    48. Systolic Blood Pressure [5 years]

      Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.

    49. Systolic Blood Pressure [5.5 years]

      Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.

    50. Systolic Blood Pressure [6 years]

      Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.

    51. Diastolic Blood Pressure [4 years]

      Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.

    52. Diastolic Blood Pressure [4.5 years]

      Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.

    53. Diastolic Blood Pressure [5 years]

      Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.

    54. Diastolic Blood Pressure [5.5 years]

      Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.

    55. Diastolic Blood Pressure [6 years]

      Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.

    56. Heart Rate [4 years]

      Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.

    57. Heart Rate [4.5 years]

      Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.

    58. Heart Rate [5 years]

      Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.

    59. Heart Rate [5.5 years]

      Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.

    60. Heart Rate [6 years]

      Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Pregnant females 16.0-35.0 years of age (inclusive) at 8-20 weeks gestation at enrollment (date/ultrasound)

    • Agree to consume study capsules from enrollment until delivery

    • Agree to return to the study center for delivery

    • BMI < 40

    • No serious illnesses (e.g., cancer, diabetes, lupus, hepatitis, sexually transmitted diseases, not HIV positive)

    • Available by telephone

    Exclusion Criteria:

    • Less than 16 or greater than 35 years of age

    • BMI < 40

    • Serious illness such as cancer, lupus, hepatitis, sexually transmitted disease or HIV positive

    • Expecting multiple infants

    • Diabetes or gestational diabetes at baseline

    • Elevated blood pressure due to any cause

    • Not planning to return to the study center for delivery

    • Gestational age at baseline < 8 weeks or >20 weeks

    • Unable or unwilling to agree to consume capsules until delivery

    • Unable to provide informed consent in English

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Kansas Medical Center Kansas City Kansas United States 66160

    Sponsors and Collaborators

    • Susan Carlson, PhD
    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    Investigators

    • Principal Investigator: Susan E Carlson, PhD, University of Kansas Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Susan Carlson, PhD, Professor, University of Kansas Medical Center
    ClinicalTrials.gov Identifier:
    NCT02487771
    Other Study ID Numbers:
    • 11406
    • 1R01HD047315
    First Posted:
    Jul 1, 2015
    Last Update Posted:
    Feb 7, 2018
    Last Verified:
    Jan 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Susan Carlson, PhD, Professor, University of Kansas Medical Center
    DHA
    childhood development

    Study Results

    Participant Flow

    Recruitment Details Participants were recruited from 7/17/2008 to 4/24/2012.
    Pre-assignment Detail Participants were required to have been enrolled in the parent trial.
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Period Title: Overall Study
    STARTED 91 99
    COMPLETED 81 85
    NOT COMPLETED 10 14

    Baseline Characteristics

    Arm/Group Title Placebo Capsule DHA Capsule Total
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule Total of all reporting groups
    Overall Participants 91 99 190
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    2.01
    (0.03)
    2.01
    (0.03)
    2.01
    (0.03)
    Sex: Female, Male (Count of Participants)
    Female
    40
    44%
    55
    55.6%
    95
    50%
    Male
    51
    56%
    44
    44.4%
    95
    50%
    Race/Ethnicity, Customized (Count of Participants)
    Hispanic
    10
    11%
    9
    9.1%
    19
    10%
    Not Hispanic
    81
    89%
    90
    90.9%
    171
    90%
    Race/Ethnicity, Customized (Count of Participants)
    Black
    33
    36.3%
    33
    33.3%
    66
    34.7%
    Not Black
    58
    63.7%
    66
    66.7%
    124
    65.3%
    Region of Enrollment (Count of Participants)
    United States
    91
    100%
    99
    100%
    190
    100%

    Outcome Measures

    1. Primary Outcome
    Title Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ
    Description The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
    Time Frame 36 Months

    Outcome Measure Data

    Analysis Population Description
    Missing data for participants dues to attrition, missed appointments, refusals, or questionable test.
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 74 88
    Mean (Standard Deviation) [units on a scale]
    98.78
    (15.43)
    98.75
    (15.75)
    2. Primary Outcome
    Title Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ
    Description The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
    Time Frame 48 Months

    Outcome Measure Data

    Analysis Population Description
    Missing data for participants dues to attrition, missed appointments, refusals, or questionable test.
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 66 79
    Mean (Standard Deviation) [units on a scale]
    97.52
    (15.32)
    99.72
    (16.10)
    3. Primary Outcome
    Title Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Full Scale IQ
    Description The Full Scale IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's general intellectual ability based upon assessments of verbal, cognitive, and performance domains. At three years the Full Scale IQ score has a range of 41 (poorest performance) to 155 (best performance). For the older ages the score can range from 40 to 160. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
    Time Frame 72 Months

    Outcome Measure Data

    Analysis Population Description
    Missing data for participants dues to attrition, missed appointments, refusals, or questionable test.
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 69 81
    Mean (Standard Deviation) [units on a scale]
    100.67
    (14.70)
    102.21
    (14.02)
    4. Primary Outcome
    Title Cognitive Function Score - Peabody Picture Vocabulary Test
    Description The Peabody Picture Vocabulary Test, 3rd Edition provides a standardized assessment of a person's receptive vocabulary. The Standard Score can range from 40 (poorest performance) to 160 (best performance) and has been normed to a Mean = 100, St Dev = 15.
    Time Frame 60 Months

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments, refusals, or questionable test.
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 74 85
    Mean (Standard Deviation) [units on a scale]
    101.07
    (14.92)
    102.35
    (15.33)
    5. Primary Outcome
    Title Cognitive Function Score - Test of Preschool Early Literacy
    Description The Test of Preschool Early Literacy provides a standardized Early Literacy Index score, a measure of general, early literacy skills that relate to later reading and writing skill acquisition. The score is based on assessments of vocabulary, print knowledge, and phonological awareness. The score can range from 40 (poorest performance) to 144 (best performance) and has been normed to a Mean = 100, St Dev = 15.
    Time Frame 42 Months

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments, refusals, or questionable test.
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 71 87
    Mean (Standard Deviation) [units on a scale]
    92.99
    (18.76)
    95.08
    (18.80)
    6. Primary Outcome
    Title Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ
    Description The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
    Time Frame 36 Months

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments, refusals, or questionable test
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 77 91
    Mean (Standard Deviation) [units on a scale]
    100.98
    (14.22)
    101.10
    (16.51)
    7. Primary Outcome
    Title Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ
    Description The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
    Time Frame 48 Months

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments, refusals, or questionable test
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 67 80
    Mean (Standard Deviation) [units on a scale]
    99.30
    (15.31)
    100.13
    (16.13)
    8. Primary Outcome
    Title Weschler Preschool and Primary Scale of Intelligence, 3rd Edition; Verbal IQ
    Description The Verbal IQ score from the Weschler Preschool and Primary Scale of Intelligence, 3rd Edition is a standardized measure of a child's verbal ability based upon assessments of vocabulary, general knowledge, and reasoning. At three years the Verbal IQ score has a range of 49 (poorest performance) to 150 (best performance). For the older ages the score can range from 46 to 155. For all ages the assessment is normed to a Mean = 100, St Dev = 15.
    Time Frame 72 Months

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments, refusals, or questionable test
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 70 81
    Mean (Standard Deviation) [units on a scale]
    101.53
    (14.20)
    102.44
    (14.88)
    9. Secondary Outcome
    Title Adaptive Regulation Assessment
    Description The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.
    Time Frame 36 Months

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments, refusals.
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 71 82
    Externalizing Problems
    48.17
    (6.86)
    49.11
    (7.85)
    Internalizing Problems
    49.31
    (9.67)
    49.10
    (8.05)
    Behavioral Symptoms
    47.99
    (7.13)
    49.46
    (6.85)
    Adaptive Skills
    54.00
    (7.49)
    52.56
    (7.23)
    10. Secondary Outcome
    Title Adaptive Regulation Assessment
    Description The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.
    Time Frame 48 Months

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments, refusals.
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 74 85
    Externalizing Problems
    48.87
    (8.22)
    50.08
    (8.22)
    Internalizing Problems
    47.30
    (8.65)
    47.46
    (8.73)
    Behavioral Symptoms
    49.42
    (8.62)
    50.59
    (7.20)
    Adaptive Skills
    50.15
    (8.76)
    47.72
    (8.40)
    11. Secondary Outcome
    Title Adaptive Regulation Assessment
    Description The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.
    Time Frame 60 Months

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments, refusals.
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 72 83
    Externalizing Problems
    48.94
    (8.71)
    50.43
    (9.22)
    Internalizing Problems
    49.99
    (7.96)
    49.21
    (8.75)
    Behavioral Symptoms
    50.17
    (7.66)
    50.78
    (8.19)
    Adaptive Skills
    52.09
    (8.18)
    50.96
    (8.13)
    12. Secondary Outcome
    Title Adaptive Regulation Assessment
    Description The Parent Rating Scales of the Behavior Assessment System for Children 2nd Edition measures different aspects of a child's behaviors as reported by a parent. Externalizing Problems is a measure of Aggression and Hyperactivity. Internalizing Problems is a measure of Anxiety, Depression, and Somatization. The Behavioral Symptoms Index is a more global measure of behavior problems and combines Externalizing Problems with the measure of Depression from Internalizing Problems, and additional measures of Atypicality, Withdrawal, and Attention Problems. Adaptive Skills is a measure of Adaptability, Social Skills, Activities of Daily Living, Functional Communication, and at age 6 years Leadership. All scores are derived from the general, combined sex normative tables of T-Scores. For Adaptive Skills higher T-Scores reflect a more optimal outcome. For all other measures lower T-Scores reflect a more optimal outcome. All T-Scores were standardized with a Mean = 50, St Dev = 10.
    Time Frame 72 Months

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments, refusals.
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 67 75
    Externalizing Problems
    50.10
    (9.68)
    49.37
    (6.76)
    Internalizing Problems
    46.80
    (7.80)
    45.96
    (8.35)
    Behavioral Symptoms
    48.99
    (8.09)
    49.17
    (6.72)
    Adaptive Skills
    51.80
    (8.09)
    49.73
    (9.77)
    13. Other Pre-specified Outcome
    Title Anthropometrics: Weight-for-age
    Description Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
    Time Frame 2 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 85 97
    Mean (Standard Deviation) [Kilogram (kg)]
    12.66
    (1.51)
    12.99
    (1.44)
    14. Other Pre-specified Outcome
    Title Anthropometrics: Weight-for-age
    Description Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
    Time Frame 2.5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 86 97
    Mean (Standard Deviation) [Kilogram (kg)]
    13.70
    (1.66)
    14.08
    (1.51)
    15. Other Pre-specified Outcome
    Title Anthropometrics: Weight-for-age
    Description Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
    Time Frame 3 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 87 97
    Mean (Standard Deviation) [Kilogram (kg)]
    14.83
    (1.76)
    15.16
    (1.60)
    16. Other Pre-specified Outcome
    Title Anthropometrics: Height-for-Age
    Description Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
    Time Frame 2 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 83 97
    Mean (Standard Deviation) [Centimeters (cm)]
    85.91
    (3.42)
    86.54
    (3.09)
    17. Other Pre-specified Outcome
    Title Anthropometrics: Weight-for-age
    Description Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
    Time Frame 3.5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 85 95
    Mean (Standard Deviation) [Kilogram (kg)]
    15.90
    (1.91)
    16.36
    (1.85)
    18. Other Pre-specified Outcome
    Title Anthropometrics: Weight-for-age
    Description Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
    Time Frame 4 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 87 91
    Mean (Standard Deviation) [Kilogram (kg)]
    17.13
    (2.11)
    17.71
    (2.10)
    19. Other Pre-specified Outcome
    Title Anthropometrics: Weight-for-age
    Description Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
    Time Frame 4.5 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 86 91
    Mean (Standard Deviation) [Kilogram (kg)]
    18.29
    (2.38)
    18.96
    (2.55)
    20. Other Pre-specified Outcome
    Title Anthropometrics: Weight-for-age
    Description Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
    Time Frame 5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 83 88
    Mean (Standard Deviation) [Kilogram (kg)]
    19.75
    (2.85)
    20.33
    (3.05)
    21. Other Pre-specified Outcome
    Title Anthropometrics: Weight-for-age
    Description Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
    Time Frame 5.5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 81 85
    Mean (Standard Deviation) [Kilogram (kg)]
    21.23
    (3.5)
    21.73
    (3.18)
    22. Other Pre-specified Outcome
    Title Anthropometrics: Weight-for-age
    Description Biannually child weight was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 kg on an electronic scale (Cardinal Detecto 8430, Webb City, MS, USA).
    Time Frame 6 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 81 85
    Mean (Standard Deviation) [Kilogram (kg)]
    22.68
    (4.16)
    23.14
    (3.66)
    23. Other Pre-specified Outcome
    Title Anthropometrics: Height-for-Age
    Description Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
    Time Frame 2.5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 86 96
    Mean (Standard Deviation) [Centimeters (cm)]
    90.66
    (3.10)
    91.17
    (3.69)
    24. Other Pre-specified Outcome
    Title Anthropometrics: Height-for-Age
    Description Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
    Time Frame 3 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 87 96
    Mean (Standard Deviation) [Centimeters (cm)]
    94.90
    (3.48)
    95.29
    (3.52)
    25. Other Pre-specified Outcome
    Title Anthropometrics: Height-for-Age
    Description Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
    Time Frame 3.5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 85 95
    Mean (Standard Deviation) [Centimeters (cm)]
    98.96
    (3.79)
    99.27
    (3.58)
    26. Other Pre-specified Outcome
    Title Anthropometrics: Height-for-Age
    Description Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
    Time Frame 4 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 87 91
    Mean (Standard Deviation) [Centimeters (cm)]
    102.77
    (3.82)
    103.32
    (3.91)
    27. Other Pre-specified Outcome
    Title Anthropometrics: Height-for-Age
    Description Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
    Time Frame 4.5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 86 91
    Mean (Standard Deviation) [Centimeters (cm)]
    106.39
    (4.23)
    107.11
    (4.09)
    28. Other Pre-specified Outcome
    Title Anthropometrics: Height-for-Age
    Description Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
    Time Frame 5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 83 88
    Mean (Standard Deviation) [Centimeters (cm)]
    110.03
    (4.30)
    110.58
    (4.23)
    29. Other Pre-specified Outcome
    Title Anthropometrics: Height-for-Age
    Description Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
    Time Frame 5.5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 81 85
    Mean (Standard Deviation) [Centimeters (cm)]
    113.41
    (4.39)
    114.01
    (4.34)
    30. Other Pre-specified Outcome
    Title Anthropometrics: Height-for-Age
    Description Biannually child stature was measured one time standing without shoes and in the lightest layer of clothing to the nearest 0.1 cm using a wall mounted statiometer (Health O Meter® Professional, McCook IL, USA). Braids, ponytails or other hair artifacts were removed or subtracted when needed.
    Time Frame 6 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 81 85
    Mean (Standard Deviation) [Centimeters (cm)]
    116.76
    (4.74)
    117.22
    (4.60)
    31. Other Pre-specified Outcome
    Title Anthropometrics: Body Mass Index-for-age
    Description Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
    Time Frame 2 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 83 97
    Mean (Standard Deviation) [Body mass index (kg/m^2)]
    17.13
    (1.53)
    17.31
    (1.28)
    32. Other Pre-specified Outcome
    Title Anthropometrics: Body Mass Index-for-age
    Description Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
    Time Frame 2.5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 85 94
    Mean (Standard Deviation) [Body mass index (kg/m2)]
    16.65
    (1.37)
    16.92
    (1.27)
    33. Other Pre-specified Outcome
    Title Anthropometrics: Body Mass Index-for-age
    Description Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
    Time Frame 3 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 87 96
    Mean (Standard Deviation) [Body mass index (kg/m2)]
    16.44
    (1.33)
    16.67
    (1.25)
    34. Other Pre-specified Outcome
    Title Anthropometrics: Body Mass Index-for-age
    Description Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
    Time Frame 3.5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 85 95
    Mean (Standard Deviation) [Body mass index (kg/m2)]
    16.21
    (1.36)
    16.57
    (1.32)
    35. Other Pre-specified Outcome
    Title Anthropometrics: Body Mass Index-for-age
    Description Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
    Time Frame 4 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 87 91
    Mean (Standard Deviation) [Body mass index (kg/m2)]
    16.18
    (1.38)
    16.56
    (1.46)
    36. Other Pre-specified Outcome
    Title Anthropometrics: Body Mass Index-for-age
    Description Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
    Time Frame 4.5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 86 91
    Mean (Standard Deviation) [Body mass index (kg/m2)]
    16.12
    (1.51)
    16.49
    (1.74)
    37. Other Pre-specified Outcome
    Title Anthropometrics: Body Mass Index-for-age
    Description Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
    Time Frame 5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 83 88
    Mean (Standard Deviation) [Body mass index (kg/m2)]
    16.27
    (1.83)
    16.58
    (1.97)
    38. Other Pre-specified Outcome
    Title Anthropometrics: Body Mass Index-for-age
    Description Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
    Time Frame 5.5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 81 85
    Mean (Standard Deviation) [Body mass index (kg/m2)]
    16.46
    (2.22)
    16.68
    (1.95)
    39. Other Pre-specified Outcome
    Title Anthropometrics: Body Mass Index-for-age
    Description Biannually child body mass index (BMI) was calculated using the standard equation: BMI = kg/m^2.
    Time Frame 6 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 81 85
    Mean (Standard Deviation) [Body mass index (kg/m2)]
    16.57
    (2.51)
    16.81
    (2.27)
    40. Other Pre-specified Outcome
    Title Anthropometrics: Head Circumference-for-age
    Description Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
    Time Frame 2 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 81 94
    Mean (Standard Deviation) [Centimeters (cm)]
    48.40
    (1.29)
    48.50
    (1.38)
    41. Other Pre-specified Outcome
    Title Anthropometrics: Head Circumference-for-age
    Description Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
    Time Frame 2.5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 85 95
    Mean (Standard Deviation) [Centimeters (cm)]
    49.18
    (1.36)
    49.21
    (1.37)
    42. Other Pre-specified Outcome
    Title Anthropometrics: Head Circumference-for-age
    Description Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
    Time Frame 3 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 87 97
    Mean (Standard Deviation) [Centimeters (cm)]
    49.64
    (1.34)
    49.75
    (1.34)
    43. Other Pre-specified Outcome
    Title Anthropometrics: Head Circumference-for-age
    Description Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
    Time Frame 3.5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 84 95
    Mean (Standard Deviation) [Centimeters (cm)]
    50.05
    (1.35)
    50.15
    (1.28)
    44. Other Pre-specified Outcome
    Title Anthropometrics: Head Circumference-for-age
    Description Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
    Time Frame 4 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 86 91
    Mean (Standard Deviation) [Centimeters (cm)]
    50.47
    (1.37)
    50.62
    (1.33)
    45. Other Pre-specified Outcome
    Title Anthropometrics: Head Circumference-for-age
    Description Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
    Time Frame 4.5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 86 91
    Mean (Standard Deviation) [Centimeters (cm)]
    50.78
    (1.36)
    50.95
    (1.42)
    46. Other Pre-specified Outcome
    Title Anthropometrics: Head Circumference-for-age
    Description Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
    Time Frame 5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 83 88
    Mean (Standard Deviation) [Centimeters (cm)]
    51.04
    (1.48)
    51.37
    (1.48)
    47. Other Pre-specified Outcome
    Title Anthropometrics: Head Circumference-for-age
    Description Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
    Time Frame 5.5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 81 84
    Mean (Standard Deviation) [Centimeters (cm)]
    51.48
    (1.42)
    51.58
    (1.42)
    48. Other Pre-specified Outcome
    Title Anthropometrics: Head Circumference-for-age
    Description Biannually child head circumference was measured to the nearest 0.1 cm using standard technique (tape positioned just above the eyebrows, above the ears and around the biggest part of the back of the head; tape pulled snuggly to compress hair and underlying soft tissue). Braids, ponytails, glasses or other artifacts were removed whenever possible.
    Time Frame 6 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 80 84
    Mean (Standard Deviation) [Centimeters (cm)]
    51.77
    (1.51)
    51.93
    (1.59)
    49. Other Pre-specified Outcome
    Title Dietary Intake
    Description Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
    Time Frame 2 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments, refusals or questionable intake
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 76 88
    Mean (Standard Deviation) [kilocalorie]
    1226
    (384)
    1210
    (439)
    50. Other Pre-specified Outcome
    Title Dietary Intake
    Description Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
    Time Frame 2.5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments, refusals or questionable intake
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 75 88
    Mean (Standard Deviation) [kilocalorie]
    1256
    (413)
    1234
    (396)
    51. Other Pre-specified Outcome
    Title Dietary Intake
    Description Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
    Time Frame 3 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments, refusals or questionable intake
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 74 90
    Mean (Standard Deviation) [kilocalorie]
    1364
    (418)
    1285
    (415)
    52. Other Pre-specified Outcome
    Title Dietary Intake
    Description Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
    Time Frame 3.5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments, refusals or questionable intake
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 77 86
    Mean (Standard Deviation) [kilocalorie]
    1340
    (361)
    1275
    (407)
    53. Other Pre-specified Outcome
    Title Dietary Intake
    Description Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
    Time Frame 4 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments, refusals or questionable intake
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 76 82
    Mean (Standard Deviation) [kilocalorie]
    1468
    (472)
    1388
    (398)
    54. Other Pre-specified Outcome
    Title Dietary Intake
    Description Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
    Time Frame 4.5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments, refusals or questionable intake
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 79 84
    Mean (Standard Deviation) [kilocalorie]
    1459
    (439)
    1432
    (423)
    55. Other Pre-specified Outcome
    Title Dietary Intake
    Description Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
    Time Frame 5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments, refusals or questionable intake
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 73 75
    Mean (Standard Deviation) [kilocalorie]
    1412
    (380)
    1466
    (479)
    56. Other Pre-specified Outcome
    Title Dietary Intake
    Description Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
    Time Frame 5.5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments, refusals or questionable intake
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 64 73
    Mean (Standard Deviation) [kilocalorie]
    1557
    (436)
    1532
    (458)
    57. Other Pre-specified Outcome
    Title Dietary Intake
    Description Biannually a registered dietitian assessed child diet by a standardized 24 hour dietary recall with three-pass approach. When necessary both the parent and child participated in the recall process to increase overall reliability. Recalls were entered into Nutrition Data System for Research (NDS-R versions 2006-2016, University of Minnesota, Minneapolis, MN, USA) and were checked for accuracy by a second dietitian. Reliability and caloric intake data are presented here. Reliability is defined as the dietitian's subjective assessment of the family's ability to recall the majority of food items consumed during the 24 hour period and within reasonable serving sizes. Caloric intake is the mean kcal per day from reliable recalls only.
    Time Frame 6 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments, refusals or questionable intake
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 70 73
    Mean (Standard Deviation) [kilocalorie]
    1655
    (487)
    1495
    (469)
    58. Other Pre-specified Outcome
    Title Systolic Blood Pressure
    Description Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
    Time Frame 4 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 78 86
    Mean (Standard Deviation) [Millimeters of mercury (mmHg)]
    100.0
    (10.8)
    98.7
    (8.3)
    59. Other Pre-specified Outcome
    Title Systolic Blood Pressure
    Description Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
    Time Frame 4.5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 81 85
    Mean (Standard Deviation) [Millimeters of mercury (mmHg)]
    101.0
    (8.7)
    100.3
    (7.6)
    60. Other Pre-specified Outcome
    Title Systolic Blood Pressure
    Description Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
    Time Frame 5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 78 83
    Mean (Standard Deviation) [Millimeters of mercury (mmHg)]
    99.5
    (7.1)
    98.2
    (8.3)
    61. Other Pre-specified Outcome
    Title Systolic Blood Pressure
    Description Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
    Time Frame 5.5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 77 84
    Mean (Standard Deviation) [Millimeters of mercury (mmHg)]
    102.1
    (8.1)
    103.5
    (9.1)
    62. Other Pre-specified Outcome
    Title Systolic Blood Pressure
    Description Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
    Time Frame 6 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 76 83
    Mean (Standard Deviation) [Millimeters of mercury (mmHg)]
    99.6
    (8.1)
    98.9
    (7.7)
    63. Other Pre-specified Outcome
    Title Diastolic Blood Pressure
    Description Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
    Time Frame 4 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 78 86
    Mean (Standard Deviation) [Millimeters of mercury (mmHg)]
    62.1
    (11.2)
    58.8
    (7.7)
    64. Other Pre-specified Outcome
    Title Diastolic Blood Pressure
    Description Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
    Time Frame 4.5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 81 85
    Mean (Standard Deviation) [Millimeters of mercury (mmHg)]
    63.3
    (9.5)
    61.0
    (6.8)
    65. Other Pre-specified Outcome
    Title Diastolic Blood Pressure
    Description Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
    Time Frame 5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 78 83
    Mean (Standard Deviation) [Millimeters of mercury (mmHg)]
    58.9
    (5.9)
    58.3
    (7.7)
    66. Other Pre-specified Outcome
    Title Diastolic Blood Pressure
    Description Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
    Time Frame 5.5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 77 84
    Mean (Standard Deviation) [Millimeters of mercury (mmHg)]
    62.5
    (8.0)
    61.5
    (7.6)
    67. Other Pre-specified Outcome
    Title Diastolic Blood Pressure
    Description Biannually child blood pressure was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
    Time Frame 6 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 76 83
    Mean (Standard Deviation) [Millimeters of mercury (mmHg)]
    60.1
    (6.1)
    59.0
    (5.3)
    68. Other Pre-specified Outcome
    Title Heart Rate
    Description Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
    Time Frame 4 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 78 86
    Mean (Standard Deviation) [Beats per minute (BPM)]
    92.6
    (9.9)
    93.1
    (12.0)
    69. Post-Hoc Outcome
    Title Anthropometrics: Body Composition
    Description Child body composition was measured between 5 and 6 years of age by BOD POD air displacement plethysmography (COSMED, Concord, CA, USA). Methods adhered to standard testing protocol (tight-fitting one-piece swimsuit and swim cap, duplicate or triplicate measure of body volume and predicted thoracic gas volume). Fat and fat free mass to the nearest 0.1 kg are presented as means with standard deviations. Normative data are not available in this pediatric population.
    Time Frame 5 to 5.5 years old

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 76 78
    Fat Mass
    4.89
    (1.59)
    5.17
    (1.66)
    Fat Free Mass
    14.60
    (2.31)
    15.18
    (2.10)
    70. Other Pre-specified Outcome
    Title Heart Rate
    Description Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
    Time Frame 4.5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 81 85
    Mean (Standard Deviation) [Beats per minute (BPM)]
    91.1
    (10.7)
    91.1
    (9.0)
    71. Other Pre-specified Outcome
    Title Heart Rate
    Description Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
    Time Frame 5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 78 83
    Mean (Standard Deviation) [Beats per minute (BPM)]
    90.4
    (10.7)
    90.4
    (9.6)
    72. Other Pre-specified Outcome
    Title Heart Rate
    Description Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
    Time Frame 5.5 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 77 84
    Mean (Standard Deviation) [Beats per minute (BPM)]
    87.9
    (12.4)
    87.2
    (11.0)
    73. Other Pre-specified Outcome
    Title Heart Rate
    Description Biannually child heart rate was measured in triplicate using an automatic pressure cuff (GE Carescape V100, Chicago, IL, USA) while children were seated in a resting state. Raw averages are reported here, including outliers. Not all subjects participated in triplicate measures.
    Time Frame 6 years

    Outcome Measure Data

    Analysis Population Description
    Missing data due to attrition, missed appointments or refusals
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    Measure Participants 76 83
    Mean (Standard Deviation) [Beats per minute (BPM)]
    84.2
    (11)
    85.4
    (10.8)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description Adverse events were not analyzed as part of this follow up.
    Arm/Group Title Placebo Capsule DHA Capsule
    Arm/Group Description Placebo Capsule: 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA DHA: 600 mg DHA capsule
    All Cause Mortality
    Placebo Capsule DHA Capsule
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Placebo Capsule DHA Capsule
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/0 (NaN)
    Other (Not Including Serious) Adverse Events
    Placebo Capsule DHA Capsule
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/0 (NaN) 0/0 (NaN)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Susan Carlson, PhD
    Organization University of Kansas Medical Center
    Phone (913) 588-5359
    Email SCARLSON@kumc.edu
    Responsible Party:
    Susan Carlson, PhD, Professor, University of Kansas Medical Center
    ClinicalTrials.gov Identifier:
    NCT02487771
    Other Study ID Numbers:
    • 11406
    • 1R01HD047315
    First Posted:
    Jul 1, 2015
    Last Update Posted:
    Feb 7, 2018
    Last Verified:
    Jan 1, 2018