Effects of Increased Maternal Choline Intake on Child Cognitive Development

Cornell University

Status: Active, not recruiting

Conditions: Pregnancy

Treatments: Dietary Supplement: 550 mg/day Choline; Dietary Supplement: 25 mg/day Choline

Study type: Interventional

Funder types: Other

Identifiers

NCT04987099

1911009219

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 21 to 40 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Experimental Dose

Experimental group

Description:

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

Treatment:

Dietary Supplement: 550 mg/day Choline

Control Dose

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: 25 mg/day Choline