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NCT05108974 · ClinicalTrials.gov registry record · Phase 2
Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study
A Phase 2 study of Fetal Alcohol Spectrum Disorders, sponsored by Jeff Wozniak.
- Active
- Registry status
- Phase 2
- Development phase
- 62
- Enrollment target
- 1
- Study location
NCT05108974: Active Phase 2 study of Fetal Alcohol Spectrum Disorders, sponsored by Jeff Wozniak.
NCT05108974 is a Phase 2 study of Fetal Alcohol Spectrum Disorders that is active but no longer recruiting, run by Jeff Wozniak. The registered enrollment target is 62 participants, below the 100-participant average among 10 other Fetal Alcohol Spectrum Disorders trials with a reported enrollment target (38% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05108974, a Phase 2 study of Fetal Alcohol Spectrum Disorders, is active but no longer recruiting, sponsored by Jeff Wozniak.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 62 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, double-blind controlled trial of choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD). The study is comparing two administration durations (3 months vs. 6 months) of choline. The primary outcome measures are cognitive measures.
Primary Outcome
Elicited Imitation short-delay memory measure (percent correct for recall)
Conditions Studied
Interventions
- DRUG Choline Bitartrate
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2021-10-22 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 2 |
What the registry record for NCT05108974 still lists
NCT05108974 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 100-participant average among 10 other Fetal Alcohol Spectrum Disorders trials with a reported enrollment target (38% lower).
The record links to 1 condition, with Fetal Alcohol Spectrum Disorders appearing as the primary indexed condition, and to 1 intervention - of which Choline Bitartrate is the first listed.
NCT05108974 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT05108974 about?
NCT05108974 is a clinical study titled "Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study". This is a randomized, double-blind controlled trial of choline supplementation in children with Fetal Alcohol Spectrum Disorders (FASD). The study is comparing two administration durations (3 months vs. 6 months) of choline. The primary outcome measures are cognitive measures.
What is the current status of trial NCT05108974?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2021-10-22. Estimated completion is 2026-07-31.
What conditions does trial NCT05108974 study?
This clinical trial studies the following conditions: Fetal Alcohol Spectrum Disorders.
What interventions are being tested in trial NCT05108974?
The interventions under investigation include: Choline Bitartrate (DRUG).
Who is sponsoring clinical trial NCT05108974?
This trial is sponsored by Jeff Wozniak, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05108974 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
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Where NCT05108974's enrollment target sits among peer trials
62 6th of 10 higher than 5 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.
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