Choline Supplementation During Pregnancy: Impact on Attention and Social Withdrawal

Completed · Phase 1 · Has a placebo group

Conditions studied: Child Development, Prenatal Stress

In brief

The goal is to determine if providing a nutritional supplement, phosphatidylcholine, to pregnant women improves early brain development with improved brain-related development during the first four years of life. Participating pregnant women will receive either phosphatidylcholine or a placebo from approximately 16 weeks gestation through birth. The primary outcome is the child's behavior at four years of age as reported by the primary caregiver. Secondary outcomes include motor development, socio-emotional development, language development, and cognitive development. Potential contributors beyond the supplement, including maternal stress and placental function will also be assessed.

Key facts

Study ID

NCT03028857

Run by

University of Colorado, Denver

People needed

216

Starts

2017-06-12

Expected to finish

2025-12-22

Last updated by the study team

2026-01-07

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• General Health: Other than pregnancy related illnesses, physically healthy expectant mothers
• ages 18-45 years
• prepregnancy BMI>18 and <45

You may not qualify if…

• Prior history of fetal death
• Current personal history of chronic infections, including HIV
• Current personal or family history out to first degree relatives of
• Trimethylaminuria
• Homocystinuria
• Primary language other than English or Spanish
• Evidence of noncompliance

Where it is running

• UCHealth — Aurora, Colorado, United States
• Saint Joseph Hospital — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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