Choline Supplementation During Pregnancy: Impact on Attention and Social Withdrawal

• Status: Active, not recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Colorado, Denver
• Treatments: Choline

Criteria

Inclusion Criteria:

• General Health: Other than pregnancy related illnesses, physically healthy expectant mothers

• ages 18-45 years

• prepregnancy BMI>18 and <45

Exclusion Criteria:

• Prior history of fetal death

• Current personal history of chronic infections, including HIV

• Current personal or family history out to first degree relatives of

1. Trimethylaminuria

2. Homocystinuria

• Primary language other than English or Spanish

• Evidence of noncompliance