Effects of Increased Maternal Choline Intake on Child Cognitive Development

NCT ID: NCT04987099

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-13
• Study Completion Date: 2024-12-31

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.

Conditions

Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

550 mg/day Choline

Intervention Type: 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.

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.

Group Type: PLACEBO_COMPARATOR

25 mg/day Choline

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara J Strupp, PhD

Role: PRINCIPAL_INVESTIGATOR

Cornell University

Locations

Cornell University

Ithaca, New York, United States

Countries

United States

Other Identifiers

1911009219

Identifier Type: -

Identifier Source: org_study_id