NCT01911299

Brief Summary

The purpose of this study is to determine whether choline supplementation can improve cognitive functioning of children with prenatal alcohol exposure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

August 1, 2014

Status Verified

July 1, 2014

Enrollment Period

1 year

First QC Date

July 26, 2013

Last Update Submit

July 30, 2014

Conditions

Fetal Alcohol Spectrum DisordersFetal Alcohol SyndromePartial Fetal Alcohol SyndromeAlcohol-related Neurodevelopmental DisorderPrenatal Alcohol Exposure

Keywords

CholineGlycerophosphocholineCholine alphoscerateFetal alcohol spectrum disordersFetal alcohol syndromePartial fetal alcohol syndromeAlcohol-related neurodevelopmental disorderPrenatal alcohol exposureFetal Alcohol EffectsPregnancy ComplicationsAlcohol-Induced DisordersAlcohol-Related DisordersCentral Nervous System AgentsTherapeutic Uses

Outcome Measures

Primary Outcomes (1)

  • Changes in cognitive function as measured by performance on neuropsychological tasks of learning/memory, executive functions, and attention

    Baseline and 6 weeks

Secondary Outcomes (1)

  • Children's Behavior Checklist (CBCL), Behavioral Rating Inventory of Executive Function (BRIEF)

    Baseline and 6 weeks

Study Arms (2)

Choline

EXPERIMENTAL

Liquid glycerophosphocholine (GPC) supplement

Dietary Supplement: Choline

Placebo

PLACEBO COMPARATOR

Liquid placebo supplement

Dietary Supplement: placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized water

Interventions

CholineDIETARY_SUPPLEMENT

5.25 ml of liquid glycerophosphocholine (approximately 1240 mg GPC), equivalent to 625 mg of choline

Choline
placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized waterDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • English as primary language

You may not qualify if:

  • Significant physical (e.g., uncorrected visual impairment, hemiparesis) or psychiatric (e.g., psychosis) disability that would prohibit participation
  • History of neurological condition (e.g., epilepsy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Behavioral Teratology, San Diego State University

San Diego, California, 92120, United States

Location

Related Publications (1)

  • Nguyen TT, Risbud RD, Mattson SN, Chambers CD, Thomas JD. Randomized, double-blind, placebo-controlled clinical trial of choline supplementation in school-aged children with fetal alcohol spectrum disorders. Am J Clin Nutr. 2016 Dec;104(6):1683-1692. doi: 10.3945/ajcn.116.142075. Epub 2016 Nov 2.

    PMID: 27806977DERIVED

MeSH Terms

Conditions

Fetal Alcohol Spectrum DisordersPregnancy ComplicationsAlcohol-Induced DisordersAlcohol-Related Disorders

Interventions

Choline

Condition Hierarchy (Ancestors)

Fetal DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsOnium Compounds

Study Officials

  • Jennifer D. Thomas, Ph.D.

    San Diego State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director - Center for Behavioral Teratology, San Diego State University

Study Record Dates

First Submitted

July 26, 2013

First Posted

July 30, 2013

Study Start

May 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

August 1, 2014

Record last verified: 2014-07

Locations

US(1)