DHA Supplementation and Pregnancy Outcome

• Sponsor: Susan Carlson, PhD (Other)
• Overall Status: Completed
• CT.gov ID: NCT00266825
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 350
• Locations: 2
• Arms: 2
• Duration (Months): 69
• Patients Per Site: 175
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

The purpose of the study is to determine if increasing DHA intake during pregnancy can increase gestation duration and enhance infant and childhood outcomes related to visual acuity, stereoacuity, attention, and distractibility.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy	Drug: DHA; Other: Placebo capsule	Phase 3

Detailed Description

Although numerous trials show benefits of postnatal DHA supplementation for visual acuity and others show benefits for cognitive function and/or attention, studies of increased DHA exposure during fetal life are needed, especially in the US. 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: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Kansas University DHA Outcome Study (KUDOS)
• Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DHA capsules DHA capsules	Drug: DHA; 600 mg DHA; Other Names: docosahexaenoic acid
Placebo Comparator: Placebo capsules Placebo capsule	Other: Placebo capsule; Placebo capsule

Outcome Measures

Primary Outcome Measures

1. Percentage of Total Fatty Acids by Weight [at time of birth]

   Measure of RBC-phospholipid-DHA at Birth

2. Gestational Age [at time of birth]

   Gestational age of babies at time of birth in days

3. Birth Weight [at time of birth]

   Weight of baby at birth

4. Birth Length [at time of birth]

   Length of baby at birth

Secondary Outcome Measures

1. Ponderal Index [at time of birth]

   Ponderal index calculated with formula Weight (g)/length (cm)^3 * 100. It a measure of leanness of a person and is calculated as a relationship between mass and height. Commonly used in pediatrics.

2. Gender of Babies [at time of birth]

3. Cord RBC-phospholipid-DHA [at time of birth]

   Percentage of total fatty acids by weight in cord RBC

4. Head Circumference [at time of birth]

   Measure of circumference of baby's head in centimeters at time of birth.

5. Preterm Births [births before week 37 of gestation]

   Percentage of births occurring at less than 37 weeks of gestation.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 36 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Pregnant 8-20 wks at enrollment

• single fetus

• BMI <40

Exclusion Criteria:

• diabetes (Type I, ii, GDM)

• hypertension (primary, PIH, preeclampsia/eclampsia)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
2	Truman Medical Center	Kansas City	Missouri	United States	64108

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
• Principal Investigator: John Colombo, PhD, University of Kansas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Susan Carlson, PhD, Professor, University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT00266825
• Other Study ID Numbers: 10186; R01HD047315
• First Posted: Dec 19, 2005
• Last Update Posted: Mar 14, 2016
• Last Verified: Feb 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided

Study Results

Participant Flow

Recruitment Details	Participants recruited from the Kansas City metro area. Enrollment occurred between January 2006 and November 2009.

Arm/Group Title	Placebo Capsule	DHA Supplement
Arm/Group Description	Placebo capsule Placebo capsule: Placebo capsule	DHA capsule DHA: 600 mg DHA
Period Title: Enrolled and Allocated Intervention
STARTED	172	178
COMPLETED	172	178
NOT COMPLETED	0	0
Period Title: Enrolled and Allocated Intervention
STARTED	172	178
COMPLETED	147	154
NOT COMPLETED	25	24

Baseline Characteristics

Arm/Group Title	Placebo Capsule	DHA Supplement	Total
Arm/Group Description	Placebo capsule Placebo capsule: Placebo capsule	DHA capsule DHA: 600 mg DHA	Total of all reporting groups
Overall Participants	172	178	350
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	24.8 (4.7)	25.3 (4.9)	25.0 (4.8)
Sex: Female, Male (Count of Participants)
Female	172 100%	178 100%	350 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (participants) [Number]
Black	79 45.9%	66 37.1%	145 41.4%
Not Black	93 54.1%	112 62.9%	205 58.6%
Race/Ethnicity, Customized (participants) [Number]
Hispanic	14 8.1%	14 7.9%	28 8%
Not Hispanic	158 91.9%	164 92.1%	322 92%
Region of Enrollment (participants) [Number]
United States	172 100%	178 100%	350 100%
Gestation at Enrollment (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	99.6 (26.1)	102.9 (25.3)	101.3 (25.7)

Outcome Measures

1. Primary Outcome

Title	Percentage of Total Fatty Acids by Weight
Description	Measure of RBC-phospholipid-DHA at Birth
Time Frame	at time of birth

Outcome Measure Data

Analysis Population Description

The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects.

Arm/Group Title	Placebo Capsule	DHA Supplement
Arm/Group Description	Placebo capsule Placebo capsule: Placebo capsule	DHA capsule DHA: 600 mg DHA
Measure Participants	147	154
All Subjects	4.7 (1.3)	7.3 (2.2)
Not Black Subjects (n=93, 112))	4.8 (1.3)	7.8 (2.1)
Black Subjects (n=79, 66)	4.7 (1.3)	6.2 (2.0)

2. Secondary Outcome

Title	Ponderal Index
Description	Ponderal index calculated with formula Weight (g)/length (cm)^3 * 100. It a measure of leanness of a person and is calculated as a relationship between mass and height. Commonly used in pediatrics.
Time Frame	at time of birth

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Capsule	DHA Supplement
Arm/Group Description	Placebo capsule Placebo capsule: Placebo capsule	DHA capsule DHA: 600 mg DHA
Measure Participants	147	154
Mean (Standard Deviation) [units on a scale]	2.7 (0.4)	2.7 (0.3)

3. Primary Outcome

Title	Gestational Age
Description	Gestational age of babies at time of birth in days
Time Frame	at time of birth

Outcome Measure Data

Analysis Population Description

The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects.

Arm/Group Title	Placebo Capsule	DHA Supplement
Arm/Group Description	Placebo capsule Placebo capsule: Placebo capsule	DHA capsule DHA: 600 mg DHA
Measure Participants	147	154
All Subjects	272.8 (17.0)	275.7 (11.2)
Not Black Subjects (n=93,112)	273.8 (14.0)	275.9 (9.9)
Black Subjects (n=79,66)	271.4 (20.3)	275.2 (13.3)

4. Primary Outcome

Title	Birth Weight
Description	Weight of baby at birth
Time Frame	at time of birth

Outcome Measure Data

Analysis Population Description

The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects.

Arm/Group Title	Placebo Capsule	DHA Supplement
Arm/Group Description	Placebo capsule Placebo capsule: Placebo capsule	DHA capsule DHA: 600 mg DHA
Measure Participants	147	154
All Subjects	3187 (602)	3359 (524)
Not Black Subjects (n=93,112)	3282 (529)	3489 (456)
Black Subjects (n=79,66)	3060 (671)	3110 (559)

5. Primary Outcome

Title	Birth Length
Description	Length of baby at birth
Time Frame	at time of birth

Outcome Measure Data

Analysis Population Description

The effect of DHA supplementation on study primary outcomes was determined for black and non-black subjects separately. Researchers did not compare outcomes between black and non-black subjects to determine whether they were statistically different. For measures reporting black and non-black results, there were 184 non-black and 117 black subjects.

Arm/Group Title	Placebo Capsule	DHA Supplement
Arm/Group Description	Placebo capsule Placebo capsule: Placebo capsule	DHA capsule DHA: 600 mg DHA
Measure Participants	147	154
All Subjects	49.0 (3.4)	49.7 (2.7)
Not Black Subjects (n=93,112)	49.2 (2.9)	50.0 (2.6)
Black Subjects (n=79,66)	48.6 (4.0)	49.0 (2.7)

6. Secondary Outcome

Title	Gender of Babies
Time Frame	at time of birth

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Capsule	DHA Supplement
Arm/Group Description	Placebo capsule Placebo capsule: Placebo capsule	DHA capsule DHA: 600 mg DHA
Measure Participants	147	154
Male	54	49
Female	46	51

7. Secondary Outcome

Title	Cord RBC-phospholipid-DHA
Description	Percentage of total fatty acids by weight in cord RBC
Time Frame	at time of birth

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Capsule	DHA Supplement
Arm/Group Description	Placebo capsule Placebo capsule: Placebo capsule	DHA capsule DHA: 600 mg DHA
Measure Participants	147	154
Mean (Standard Deviation) [percentage of cord RBC]	5.9 (1.4)	7.3 (1.8)

8. Secondary Outcome

Title	Head Circumference
Description	Measure of circumference of baby's head in centimeters at time of birth.
Time Frame	at time of birth

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Capsule	DHA Supplement
Arm/Group Description	Placebo capsule Placebo capsule: Placebo capsule	DHA capsule DHA: 600 mg DHA
Measure Participants	147	154
Mean (Standard Deviation) [centimeters]	33.7 (2.0)	34.2 (1.7)

9. Secondary Outcome

Title	Preterm Births
Description	Percentage of births occurring at less than 37 weeks of gestation.
Time Frame	births before week 37 of gestation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Capsule	DHA Supplement
Arm/Group Description	Placebo capsule Placebo capsule: Placebo capsule	DHA capsule DHA: 600 mg DHA
Measure Participants	147	154
Number [percentage of births]	8.8	7.8

Adverse Events

Time Frame	Researchers followed the mother for 30 days post-partum and the infant from birth to 18 months. Typical follow-up stops 30 days after the end of the intervention. Researchers collected information on each from their medical records.
Arm/Group Title	Placebo Capsule - Mother		Placebo Capsule - Infant		DHA Capsule - Mother		DHA Capsule - Infant
Arm/Group Description	Placebo capsule Placebo capsule: Placebo capsule		Infants born from Mothers in the Placebo capsule group		DHA capsule DHA: 600 mg DHA		Infants born from Mothers in the DHA capsule group
All Cause Mortality
	Placebo Capsule - Mother		Placebo Capsule - Infant		DHA Capsule - Mother		DHA Capsule - Infant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo Capsule - Mother		Placebo Capsule - Infant		DHA Capsule - Mother		DHA Capsule - Infant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/147 (12.2%)		31/147 (21.1%)		18/154 (11.7%)		26/154 (16.9%)
Congenital, familial and genetic disorders
Congenital anomalies	0/0 (NaN)	0	2/147 (1.4%)	2	0/0 (NaN)	0	5/154 (3.2%)	5
Pregnancy, puerperium and perinatal conditions
Hospitalization or miscarriage	18/147 (12.2%)	18	0/0 (NaN)	0	18/154 (11.7%)	18	0/0 (NaN)	0
Hospitalization and death	0/0 (NaN)	0	31/147 (21.1%)	31	0/0 (NaN)	0	26/154 (16.9%)	26
Postpartum hospitalization	3/147 (2%)	3	0/0 (NaN)	0	1/154 (0.6%)	1	0/0 (NaN)	0
Other (Not Including Serious) Adverse Events
	Placebo Capsule - Mother		Placebo Capsule - Infant		DHA Capsule - Mother		DHA Capsule - Infant
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/147 (0%)		0/147 (0%)		0/154 (0%)		0/154 (0%)

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.