← Back to Search

Other

Choline Supplementation for Fetal Alcohol Spectrum Disorders (CHOLINE4 Trial)

Phase 2
Recruiting
Led By Jeffrey R Wozniak, Ph.D.
Research Sponsored by Jeff Wozniak
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 2.5 years to 5 years old (<6 years of age) at enrollment
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 9 months
Awards & highlights

CHOLINE4 Trial Summary

This trial is testing whether choline supplements can improve cognitive function in children with Fetal Alcohol Spectrum Disorders.

Who is the study for?
This trial is for children aged between 2.5 and 5 years who have been exposed to alcohol before birth and have a guardian able to consent. It's not for kids with conditions affecting brain function, other neurodevelopmental disorders like autism or Down syndrome, epilepsy, traumatic brain injuries, or those born weighing less than 1500 grams.Check my eligibility
What is being tested?
The study tests if choline bitartrate supplements can help with cognitive development in kids with Fetal Alcohol Spectrum Disorders. It compares the effects of taking the supplement for either three months or six months in a randomized and double-blind setup.See study design
What are the potential side effects?
Choline supplementation may cause minor side effects such as fishy body odor, vomiting, sweating, digestive issues like diarrhea or constipation; however these are generally considered rare and mild.

CHOLINE4 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 2.5 and 5 years old.

CHOLINE4 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Elicited Imitation Memory Task (EI) (P.J. Bauer et al 1992 laboratory paradigm)
Minnesota Executive Function Scale (MEFS)
NIH Toolbox Flanker Test
+2 more
Secondary outcome measures
Child Behavior Checklist (CBCL)

CHOLINE4 Trial Design

2Treatment groups
Experimental Treatment
Group I: 6 months choline bitartrateExperimental Treatment1 Intervention
Over the 9-month study, participants will receive a total of 6 months of choline bitartrate (19 mg/kg) and a total of 3 months of placebo
Group II: 3 months choline bitartrateExperimental Treatment1 Intervention
Over the 9-month study, participants will receive a total of 3 months of choline bitartrate (19 mg/kg) and a total of 6 months of placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Choline Bitartrate
2016
Completed Phase 4
~150

Find a Location

Who is running the clinical trial?

Jeff WozniakLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
801 Previous Clinical Trials
1,365,337 Total Patients Enrolled
14 Trials studying Fetal Alcohol Spectrum Disorders
3,601 Patients Enrolled for Fetal Alcohol Spectrum Disorders
Jeffrey R Wozniak, Ph.D.Principal InvestigatorUniversity of Minnesota
3 Previous Clinical Trials
176 Total Patients Enrolled
3 Trials studying Fetal Alcohol Spectrum Disorders
176 Patients Enrolled for Fetal Alcohol Spectrum Disorders

Media Library

Choline Bitartrate (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05108974 — Phase 2
Fetal Alcohol Spectrum Disorders Research Study Groups: 6 months choline bitartrate, 3 months choline bitartrate
Fetal Alcohol Spectrum Disorders Clinical Trial 2023: Choline Bitartrate Highlights & Side Effects. Trial Name: NCT05108974 — Phase 2
Choline Bitartrate (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05108974 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are enrolled in this experiment?

"Yes, as specified on clinicaltrials.gov, this trial is still recruiting patients. The listing for the study was first posted on October 22nd 2021 and updated November 17th 2021. They are looking to enroll 60 individuals at a single site."

Answered by AI

Could you tell me if this research is still recruiting participants?

"Yes, this trial is still looking for participants and was originally posted on October 22nd, 2021 with the most recent update being November 17th, 2021."

Answered by AI

Who would be eligible to sign up for this trial?

"Sixty patients with fetal alcohol syndrome, aged between 30 and 72 months, are what this trial needs. The most crucial detail is that potential participants must be 2.5 to 5 years old (<6 years of age) when they enroll in the study."

Answered by AI

Is it legal to sell Choline Bitartrate in the United States?

"Choline Bitartrate falls into the Phase 2 category, meaning that while there is data backing its safety, there is yet to be any evidence of it being an effective treatment. Therefore, our team has given it a score of 2."

Answered by AI

What other research has been conducted that includes Choline Bitartrate?

"There are 9 current clinical trials evaluating Choline Bitartrate. Of these, 2 are large-scale Phase 3 studies. The majority of research is happening in Montréal, Quebec; however, this treatment is being studied at 10 different locations."

Answered by AI

Will this test be able to provide data for patients that are older?

"Per the inclusion criteria listed on this study, patients between 30 and 72 months old may apply. There are 9 similar trials for those under 18 years of age and 11 for seniors."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study
Jeff Wozniak 2021. "Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05108974.
~29 spots leftby Aug 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top