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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 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.

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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.

Conditions Studied

Fetal Alcohol Spectrum Disorders

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

Sponsor

University of Minnesota

966 total trials

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What the Registry Record Tells You About NCT02735473

The ClinicalTrials.gov registry entry for NCT02735473 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 102-participant average among 10 other Fetal Alcohol Spectrum Disorders trials with a reported enrollment target (55% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.