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Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders

NCT02735473 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2022-11-01

Study results available
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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.

Conditions

  • Fetal Alcohol Spectrum Disorders

Interventions

DRUG

Choline bitartrate

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • Jeffrey R Wozniak, Ph.D. · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2021-09-10
Completion
2021-09-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02735473 on ClinicalTrials.gov