Effects of Increased Maternal Choline Intake on Child Cognitive Development

Pregnancy Clinical Trial

Official title:

Effects of Increased Maternal Choline Intake on Child Cognitive Development

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04987099
• Other study ID #: 1911009219
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2022
• Source: Cornell University
• Contact: Barbara J Strupp, PhD
• Phone: 607-227-1191
• Email: bjs13[@]cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pregnancy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Cornell University	Ithaca	New York

Sponsors (1)

Lead Sponsor	Collaborator
Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Effects of Maternal Choline Supplementation on Infant Visual Recognition Memory: Developmental Trajectory Analysis of the Novelty Preference Score	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).	Infant ages of 5, 7, 10, and 13 months
Primary	The Effects of Maternal Choline Supplementation on Infant Visual Attention: Mean Orienting Speed Score	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.	Infant ages of 5, 7, 10, and 13 months
Primary	The Effects of Maternal Choline Supplementation on Infant Sustained Focused Attention: Mean Sustained Focused Attention Score	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.	Infant ages of 5, 7, 10, and 13 months
Primary	The Effects of Maternal Choline Supplementation on Emotion Regulation: Lab-TAB/Frustation Task Scores	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.	Infant ages of 7, 10, and 13 months
Primary	The Effects of Maternal Choline Supplementation on Emotion Regulation: Face-to-Face Still-Face Paradigm Scores	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.	Infant ages of 7, 10, and 13 months