drugset / Trial / NCT03028857

Choline Supplementation During Pregnancy: Impact on Attention and Social Withdrawal

NCT03028857

Phase 1 Completed 216 enrolled University of Colorado, Denver
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2017-06-12
Primary completion
2025-12-22
Completion
2025-12-22

Drugs

EvaluationDrugModalityDoseRoute
Comparator Choline Other / unclassified 4500 mg

Indications

No indication recorded.