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Active, Not Recruiting

NCT Number: NCT04987099

Effects of Increased Maternal Choline Intake on Child Cognitive Development

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pregnancy

Age range

21 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cornell University

Ithaca, New York, 14850, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

550 mg/day Choline

Dietary Supplement

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

Dietary Supplement

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.

Primary outcomes

  1. The Effects of Maternal Choline Supplementation on Infant Visual Recognition Memory: Developmental Trajectory Analysis of the Novelty Preference Score

    Time frame: 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).

  2. The Effects of Maternal Choline Supplementation on Infant Visual Attention: Mean Orienting Speed Score

    Time frame: 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.

  3. The Effects of Maternal Choline Supplementation on Infant Sustained Focused Attention: Mean Sustained Focused Attention Score

    Time frame: 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.

  4. The Effects of Maternal Choline Supplementation on Emotion Regulation: Lab-TAB/Frustation Task Scores

    Time frame: 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.

  5. The Effects of Maternal Choline Supplementation on Emotion Regulation: Face-to-Face Still-Face Paradigm Scores

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cornell University

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 3, 2021
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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