Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05108974 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study

Study acronym: CHOLINE4
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates: Jul 31, 2026 to Jul 31, 2027v8
  2. Enrollment target: estimated 60 to confirmed 62v7
  3. Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: Aug 31, 2026 to Jul 31, 2026
    • Site details revised
    v6
  4. Study Identification, Study Status, Oversightv5
  5. 2 versions Re-verified since Dec 13, 2022, no change to tracked fieldsv3-v4
  6. Primary endpoints revised (5)v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05108974
Lead Sponsor Jeff Wozniak
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions
(from sponsor)		 Fetal Alcohol Spectrum Disorders
Related terms Fetal Alcohol Spectrum Disorders
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov