Effects of Increased Maternal Choline Intake on Child Cognitive Development

Last updated: October 1, 2024
Sponsor: Cornell University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Pregnancy

Treatment

25 mg/day Choline

550 mg/day Choline

Clinical Study ID

NCT04987099
1911009219
  • Ages 21-40
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 thestudy

  • Intending to deliver at Cayuga Medical Center

Exclusion

Exclusion Criteria:

  • Self-reported history of health conditions associated with metabolic orgastrointestinal function or adverse child outcomes

  • Current use of medications known to affect liver or kidney function or childoutcomes

  • High omega-3 fatty acid intakes from diet (as determined by a licensed registereddietitian) at screening

  • Choline supplementation that exceeds 50 mg/day at screening

  • Use of alcohol, tobacco products, or recreational drugs during pregnancy or duringthe Prenatal Phase of the study

  • Use of non-study approved or provided supplements during the Prenatal Phase of thestudy

  • Development of pregnancy-related complications during the study (i.e. gestationaldiabetes, gestational hypertension, preeclampsia, genetic abnormalities, ormiscarriage)

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: 25 mg/day Choline
Phase:
Study Start date:
December 13, 2020
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Cornell University

    Ithaca, New York 14850
    United States

    Site Not Available

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