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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
Must not have
History of a neurological condition (e.g., epilepsy, traumatic brain injury)
History of a medical condition known to affect brain function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 9 months
Awards & highlights
Summary
This trial is testing whether giving choline, a nutrient found in foods like eggs and meat, can help improve brain function in young children with Fetal Alcohol Spectrum Disorders (FASD). These children have cognitive issues due to alcohol exposure before birth. Choline might help their brains work better, especially for memory and thinking skills.
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 2.5 and 5 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of a neurological condition.
Select...
I have a medical condition that affects my brain function.
Select...
I was born weighing less than 1500 grams.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 9 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Elicited Imitation Memory Task (EI) (P.J. Bauer et al 1992 laboratory paradigm)
Minnesota Executive Function Scale (MEFS)
NIH Toolbox Flanker Test
+2 moreSecondary study objectives
Child Behavior Checklist (CBCL)
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Choline supplementation is a promising treatment for Fetal Alcohol Spectrum Disorders (FASD) due to its role in supporting neurodevelopment and cognitive function. Choline contributes to the synthesis of phospholipids, essential for cell membranes, and serves as a precursor for the neurotransmitter acetylcholine, which is crucial for memory and learning.
This mechanism is particularly important for FASD patients as it may help mitigate the neurodevelopmental deficits caused by prenatal alcohol exposure, potentially improving cognitive outcomes and overall brain health.
Neonatal choline supplementation ameliorates the effects of prenatal alcohol exposure on a discrimination learning task in rats.
Neonatal choline supplementation ameliorates the effects of prenatal alcohol exposure on a discrimination learning task in rats.
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Who is running the clinical trial?
Jeff WozniakLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
829 Previous Clinical Trials
1,081,738 Total Patients Enrolled
14 Trials studying Fetal Alcohol Spectrum Disorders
3,653 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of a neurological condition.I have a medical condition that affects my brain function.I was born weighing less than 1500 grams.I am between 2.5 and 5 years old.
Research Study Groups:
This trial has the following groups:- Group 1: 6 months choline bitartrate
- Group 2: 3 months choline bitartrate
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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