Fetal Alcohol Spectrum Disorders Clinical Trial
Official title:
Postnatal Choline Supplementation in Children With Prenatal Alcohol Exposure
The purpose of this study is to determine if choline bitartrate can be administered daily to children with prenatal alcohol exposure, ages 2.5 to 5, as a potential treatment for brain development and cognitive functioning.
Status | Completed |
Enrollment | 60 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years to 5 Years |
Eligibility |
Inclusion Criteria: - Available parent or legal guardian capable of participating in informed consent process - Documented history of heavy prenatal alcohol exposure (self-report, social service records, or adoption records) or presence of facial dysmorphology characteristic of FASD or both - Evidence of cognitive deficit in at least one neurocognitive domain Exclusion Criteria: - History of neurological condition (ex. epilepsy, cerebral palsy, traumatic brain injury) - History of medical condition known to affect brain function - History of other neurodevelopmental disorder (ex. autism, down syndrome) - History of very low birthweight (<1500 grams) - History of prenatal exposure to drugs other than alcohol, nicotine, and caffeine |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota - Clinical and Translational Science Institute | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Side Effects of Choline Bitartrate | Side effects of choline bitartrate will be monitored by the study physician and the P.I. with physical examinations and telephone contact. | 14 days, 1, 2, 3, 4, 5, 6, 7, 8 and 9 months | Yes |
Primary | Mullen Scales of Early Learning | The Mullen Scales of Early Learning is a measure of global cognitive development and is a primary outcome measure. | Baseline, 6 months, and 9 months | No |
Secondary | Elicited Imitation Task Memory | An Elicited Imtation paradigm will be used to measure memory in the participants (immediate, delayed, interleaved). | Baseline, 6 months, and 9 months | No |
Secondary | Evoked Response Potentials | Evoked response potentials will be measured for the memory task and a separate visually-evoked response task (a measure of processing speed). | Baseline, 6 months, and 9 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06163651 -
Evaluating a One-Year Version of the Parent-Child Assistance Program
|
N/A | |
Completed |
NCT01961050 -
Preventing FAS/ARND in Russian Children
|
N/A | |
Recruiting |
NCT05108974 -
Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders Study
|
Phase 2 | |
Completed |
NCT02457676 -
Improving Self Regulation in Children With Fetal Alcohol Syndrome Spectrum Disorders: A Neuroplastic Intervention
|
N/A | |
Recruiting |
NCT06005181 -
The Synchrony Study: Examining Music Training for Children With FASD
|
N/A | |
Completed |
NCT04571463 -
Ethyl Glucuronide in Urine Samples of Pregnant Women Within the HUS ja PHHYKY Area
|
||
Completed |
NCT03361293 -
Cognitive Training and tDCS for Children With FASD
|
N/A | |
Recruiting |
NCT05534568 -
The Oklahoma Parent-Child Assistance Program
|
N/A | |
Recruiting |
NCT05456321 -
CIFASD 5 tDCS and Cognitive Training
|
N/A | |
Completed |
NCT01911299 -
Choline Supplementation in Children With Fetal Alcohol Spectrum Disorders
|
Phase 2 | |
Recruiting |
NCT04332172 -
Scaling Up: A Multi-Site Trial of e-SBI for Alcohol Use in Pregnancy
|
N/A | |
Recruiting |
NCT05960461 -
Families Moving Forward (FMF) Connect Pro for Mental Health Providers
|
N/A | |
Completed |
NCT05604014 -
Feasibility Study of the My Health Coach App for Adults With FASD
|
N/A | |
Terminated |
NCT03852550 -
READYorNot[TM] Brain-Based Disabilities Trial
|
N/A | |
Completed |
NCT02735473 -
Choline Supplementation as a Neurodevelopmental Intervention in Fetal Alcohol Spectrum Disorders
|
Phase 2 | |
Completed |
NCT03782935 -
Nutritional Risk Factors for FASD in Ukraine
|
N/A | |
Not yet recruiting |
NCT04918043 -
Alcohol Use During Pregnancy in Finland According to Meconium Samples
|
||
Completed |
NCT04072809 -
Dissecting the Genetics of Fetal Alcohol Spectrum Disorders
|
||
Completed |
NCT05028517 -
Efficacy Trial of the FMF Connect Mobile Health Intervention
|
N/A | |
Completed |
NCT04194489 -
Trial of the Families Moving Forward (FMF) Connect Mobile Health Intervention
|
N/A |