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NCT01149538 · ClinicalTrials.gov registry record · Phase 1

Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure

A Phase 1 study of Fetal Alcohol Spectrum Disorders and Fetal Alcohol Syndrome, sponsored by University of Minnesota.

Completed
Registry status
Phase 1
Development phase
60
Enrollment target
1
Study location

NCT01149538: Completed Phase 1 study of Fetal Alcohol Spectrum Disorders and Fetal Alcohol Syndrome, sponsored by University of Minnesota.

NCT01149538 is a Phase 1 study of Fetal Alcohol Spectrum Disorders and Fetal Alcohol Syndrome that has completed, run by University of Minnesota. The registered enrollment target is 60 participants, below the 100-participant average among 10 other Fetal Alcohol Spectrum Disorders trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01149538, a Phase 1 study of Fetal Alcohol Spectrum Disorders and Fetal Alcohol Syndrome, has completed, sponsored by University of Minnesota.

COMPLETED
Registry status
Phase 1
Development phase
60 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to determine if choline bitartrate can be administered daily to children with prenatal alcohol exposure, ages 2.5 to 5, as a potential treatment for brain development and cognitive functioning.

Primary Outcome

Side effects of choline bitartrate will be monitored by the study physician and the P.I. with physical examinations and telephone contact.

Conditions Studied

Fetal Alcohol Spectrum Disorders Fetal Alcohol Syndrome Partial Fetal Alcohol Syndrome Alcohol Related Neurodevelopmental Disorder Prenatal Alcohol Exposure

Interventions

  • DRUG Choline bitartrate
  • DIETARY_SUPPLEMENT Placebo for choline bitartrate

Study Locations (1)

Minnesota

  • University of Minnesota - Minneapolis

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2010-07
Est. Completion 2014-09
Phase Phase 1
University of Minnesota

966 total trials

What the finished NCT01149538 record still lists

NCT01149538 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 100-participant average among 10 other Fetal Alcohol Spectrum Disorders trials with a reported enrollment target (40% lower).

The record links to 5 conditions, with Fetal Alcohol Spectrum Disorders appearing as the primary indexed condition, and to 2 interventions - of which Choline bitartrate is the first listed.

NCT01149538 reports a single indexed study location in Minnesota.

Frequently Asked Questions

What is clinical trial NCT01149538 about?

NCT01149538 is a clinical study titled "Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure". The purpose of this study is to determine if choline bitartrate can be administered daily to children with prenatal alcohol exposure, ages 2.5 to 5, as a potential treatment for brain development and cognitive functioning.

What is the current status of trial NCT01149538?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2010-07. Estimated completion is 2014-09.

What conditions does trial NCT01149538 study?

This clinical trial studies the following conditions: Fetal Alcohol Spectrum Disorders, Fetal Alcohol Syndrome, Partial Fetal Alcohol Syndrome, Alcohol Related Neurodevelopmental Disorder, Prenatal Alcohol Exposure.

What interventions are being tested in trial NCT01149538?

The interventions under investigation include: Choline bitartrate (DRUG), Placebo for choline bitartrate (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT01149538?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01149538 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Fetal Alcohol Spectrum Disorders

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01149538's enrollment target sits among peer trials

60 7th of 10 higher than 4 of 10 other Fetal Alcohol Spectrum Disorders trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Fetal Alcohol Spectrum Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01149538, the US trial registry maintained by the National Library of Medicine. NCT01149538 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.