CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
Choline bitartrate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02735473
NCT02735473Phase 2Completed
CompareCT.gov

Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders

University of Minnesota·interventional·Posted Apr 12, 2016·Updated Nov 1, 2022

In Brief

A Phase 2 clinical trial evaluating Choline bitartrate and Placebo for Fetal Alcohol Spectrum Disorders. Completed, enrolled 46 participants across 1 site.

Detailed Summary

This is a randomized, double-blind, placebo-controlled trial of choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD). The primary outcome measures are cognitive measures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFetal Alcohol Spectrum Disorders
CountriesUnited States
CollaboratorsNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 12, 2016
Enrollment StartJun 1, 2016
Primary CompletionSep 10, 2021
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 10.2 years ago

Interventions

Choline bitartratedrug

Placebodrug