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NCT02735473 · ClinicalTrials.gov registry record · Phase 2

Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders

A Phase 2 study of Fetal Alcohol Spectrum Disorders, sponsored by University of Minnesota.

Completed
Registry status
Phase 2
Development phase
46
Enrollment target
1
Study location

NCT02735473: Completed Phase 2 study of Fetal Alcohol Spectrum Disorders, sponsored by University of Minnesota.

NCT02735473 is a Phase 2 study of Fetal Alcohol Spectrum Disorders that has completed, run by University of Minnesota. The registered enrollment target is 46 participants, below the 102-participant average among 10 other Fetal Alcohol Spectrum Disorders trials with a reported enrollment target (55% 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

NCT02735473, a Phase 2 study of Fetal Alcohol Spectrum Disorders, has completed, sponsored by University of Minnesota.

COMPLETED
Registry status
Phase 2
Development phase
46 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Elicited Imitation memory paradigm - short delay memory measure at 6 months; scores are in percentage correct.

Interventions

  • DRUG Placebo
  • DRUG Choline bitartrate

Study Locations (1)

Minnesota

  • University of Minnesota - Minneapolis

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2016-06
Est. Completion 2021-09-10
Phase Phase 2
University of Minnesota

966 total trials

What the finished NCT02735473 record still lists

NCT02735473 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 102-participant average among 10 other Fetal Alcohol Spectrum Disorders trials with a reported enrollment target (55% lower).

The record links to 1 condition, with Fetal Alcohol Spectrum Disorders appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02735473 reports a single indexed study location in Minnesota.

Frequently Asked Questions

What is clinical trial NCT02735473 about?

NCT02735473 is a clinical study titled "Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders". 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.

What is the current status of trial NCT02735473?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2016-06. Estimated completion is 2021-09-10.

What conditions does trial NCT02735473 study?

This clinical trial studies the following conditions: Fetal Alcohol Spectrum Disorders.

What interventions are being tested in trial NCT02735473?

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

Who is sponsoring clinical trial NCT02735473?

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

Where is trial NCT02735473 being conducted?

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

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 NCT02735473's enrollment target sits among peer trials

46 8th of 10 higher than 3 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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Source: ClinicalTrials.gov NCT02735473, the US trial registry maintained by the National Library of Medicine. NCT02735473 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.