Clinical trial NCT04987099: Effects of Increased Maternal Choline Intake on Child Cognitive Development
Official title: Effects of Increased Maternal Choline Intake on Child Cognitive Development
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pregnancy
Keywords: Choline
Prenatal Supplementation
Pregnancy
Offspring Cognition
Offspring Emotion Regulation
Lead sponsor: Cornell University
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: The Effects of Maternal Choline Supplementation on Infant Visual Recognition Memory: Developmental Trajectory Analysis of the Novelty Preference Score
timeFrame: Infant ages of 5, 7, 10, and 13 months
measure: The Effects of Maternal Choline Supplementation on Infant Visual Attention: Mean Orienting Speed Score
timeFrame: Infant ages of 5, 7, 10, and 13 months
measure: The Effects of Maternal Choline Supplementation on Infant Sustained Focused Attention: Mean Sustained Focused Attention Score
timeFrame: Infant ages of 5, 7, 10, and 13 months
measure: The Effects of Maternal Choline Supplementation on Emotion Regulation: Lab-TAB/Frustation Task Scores
timeFrame: Infant ages of 7, 10, and 13 months
measure: The Effects of Maternal Choline Supplementation on Emotion Regulation: Face-to-Face Still-Face Paradigm Scores
timeFrame: Infant ages of 7, 10, and 13 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ithaca
country: United States
facility: Cornell University
state: New York
Study officials:
affiliation: Cornell University
name: Barbara J Strupp, PhD
role: PRINCIPAL_INVESTIGATOR
References: