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Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study

NCT05108974 ↗

Phase 2 Active not recruiting 62 enrolled Jeff Wozniak National Institute on Alcohol Abuse and Alcoholism (NIAAA) · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, double-blind controlled trial of choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD). The study is comparing two administration durations (3 months vs. 6 months) of choline. The primary outcome measures are cognitive measures.

Timeline

Start
2021-10-22
Primary completion
2027-07-31
Completion
2027-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Choline Bitartrate Small molecule 19 mg/kg —

Indications

fetal alcohol spectrum disorder