๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-07-06

Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study (NCT05108974)

๐Ÿ”ต Active, Not Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Jeff Wozniak

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (5 items).

Location: University of Minnesota โ€” Minneapolis, Minnesota

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • History of a neurological condition (ex. epilepsy, traumatic brain injury)
  • History of a medical condition known to affect brain function
  • Other neurodevelopmental disorder (ex. autism, Down syndrome)
  • History of very low birthweight (\<1500 grams)

๐Ÿ” Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • University of Minnesota โ€” Minneapolis, Minnesota

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
๐Ÿ›๏ธ View Official NIH Record โ†—