Effects of Increased Maternal Choline Intake on Child Cognitive Development

Sponsor

Cornell University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04987099

Collaborator

(none)

Enrollment

Location

Arms

48.6

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to examine cognitive and affective outcomes in the offspring of women supplemented with choline vs. control during pregnancy.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy	Dietary Supplement: 550 mg/day Choline Dietary Supplement: 25 mg/day Choline	N/A

Detailed Description

Choline, an essential nutrient, plays numerous important roles in fetal development. However

90% of pregnant women in the U.S. consume less than the recommended amount, and choline is typically absent from most prenatal vitamins. Moreover, current choline recommendations for pregnant women may be inadequate for optimal fetal development and lifelong health. Animal studies clearly show that maternal choline supplementation (MCS) improves offspring memory, attention, and emotion regulation. The purpose of this study is to examine cognitive and affective outcomes in the offspring of women supplemented with choline vs. control during the second and third trimesters of pregnancy.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Only a Laboratory Manager, who will label the supplements with participant ID, will have access to participants' study assignments.

Primary Purpose:

Treatment

Official Title:

Effects of Increased Maternal Choline Intake on Child Cognitive Development

Actual Study Start Date :

Dec 13, 2020

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Dose Participants will consume a 15 mL grape juice cocktail solution that contains 550 mg of choline once daily for the duration of their pregnancy.	Dietary Supplement: 550 mg/day Choline Choline chloride (550 mg) is a water soluble choline salt that will be provided in a grape juice cocktail solution to participants for daily consumption.
Placebo Comparator: Control Dose Participants will consume a 15 mL grape juice cocktail solution that contains 25 mg of choline once daily for the duration of their pregnancy.	Dietary Supplement: 25 mg/day Choline Choline chloride (25 mg) is a water soluble choline salt that will be provided in a grape juice cocktail solution to participants for daily consumption.

Arm

Intervention/Treatment

Experimental: Experimental Dose

Participants will consume a 15 mL grape juice cocktail solution that contains 550 mg of choline once daily for the duration of their pregnancy.

Dietary Supplement: 550 mg/day Choline

Choline chloride (550 mg) is a water soluble choline salt that will be provided in a grape juice cocktail solution to participants for daily consumption.

Placebo Comparator: Control Dose

Participants will consume a 15 mL grape juice cocktail solution that contains 25 mg of choline once daily for the duration of their pregnancy.

Dietary Supplement: 25 mg/day Choline

Choline chloride (25 mg) is a water soluble choline salt that will be provided in a grape juice cocktail solution to participants for daily consumption.

Outcome Measures

Primary Outcome Measures

The Effects of Maternal Choline Supplementation on Infant Visual Recognition Memory: Developmental Trajectory Analysis of the Novelty Preference Score [Infant ages of 5, 7, 10, and 13 months]
The composite novelty score (proportion of looking to the novel image) is obtained from a series of 9 visual paired comparison tests. The novelty score is a measure of visual recognition memory for infants and has been shown to predict cognitive outcomes in childhood. This analysis will assess developmental trajectories for performance on this task across the first year of life (ages 5, 7, 10, and 13 months).
The Effects of Maternal Choline Supplementation on Infant Visual Attention: Mean Orienting Speed Score [Infant ages of 5, 7, 10, and 13 months]
Visual attention orienting speed is measured by the latency to initiate a stimulus-guided fixation shift to a peripheral visual target (mean of up to 20 target presentations). The orienting score is found to be sensitive to maternal choline supplementation in infants of this age and has shown acceptable test-retest reliability and prediction of attention, memory, and intelligence quotient outcomes in childhood. This analysis will assess the within-subject age-adjusted mean saccade latency obtained from tests repeated at ages 5, 7, 10, and 13 months.
The Effects of Maternal Choline Supplementation on Infant Sustained Focused Attention: Mean Sustained Focused Attention Score [Infant ages of 5, 7, 10, and 13 months]
Sustained focused attention is measured during a 5-minute period in which infants are engaged in solitary play with a complex toy. The score is the average duration of infant engagement in a state of focused attention on the toy. Infants who sustain focused attention for longer durations have been found to have fewer attentional problems as children. This analysis will assess the within-subject age-adjusted mean duration of focused attention obtained from tests repeated at ages 5, 7, 10, and 13 months.
The Effects of Maternal Choline Supplementation on Emotion Regulation: Lab-TAB/Frustation Task Scores [Infant ages of 7, 10, and 13 months]
Negative affect in response to goal blockage is measured by coding of infant facial expression, vocalization, and body language over the course of four sequential task trials to produce composite scores of negative affect. Infants' ability to regulate negative affect during the task has been found to predict aggressiveness at age three and has been associated with non-compliance in toddlerhood.
The Effects of Maternal Choline Supplementation on Emotion Regulation: Face-to-Face Still-Face Paradigm Scores [Infant ages of 7, 10, and 13 months]
Infant negative affect in response to a violation of social expectations for interactions with a parent (the parent not engaging with infant's social cues and maintaining a neutral expression) is measured by coding of infant negative vocalizations (crying, screaming, etc.) over the course of three sequential task trials to produce composite scores of negative affect. Infants' behavior in this task has been shown to predict later attachment, internalizing, and externalizing behaviors in toddlerhood and early childhood.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy
Singleton pregnancy (carrying one baby)
21-40 years old
Between 12-18 weeks pregnant at the time of screening
Self-reported BMI <35.0 in the three months prior to pregnancy (estimated or known)
Willingness to comply with all study procedures for the duration of the study
Intending to live in Ithaca, NY or the surrounding area for the duration of the study
Intending to deliver at Cayuga Medical Center

Exclusion Criteria:

Self-reported history of health conditions associated with metabolic or gastrointestinal function or adverse child outcomes
Current use of medications known to affect liver or kidney function or child outcomes
High omega-3 fatty acid intakes from diet (as determined by a licensed registered dietitian) at screening
Choline supplementation that exceeds 50 mg/day at screening
Use of alcohol, tobacco products, or recreational drugs during pregnancy or during the Prenatal Phase of the study
Use of non-study approved or provided supplements during the Prenatal Phase of the study
Development of pregnancy-related complications during the study (i.e. gestational diabetes, gestational hypertension, preeclampsia, genetic abnormalities, or miscarriage)