Fetal Alcohol Spectrum Disorders Clinical Trial
Official title:
Early Identification of Affected Children and Nutritional Risk Factors for FASD in Ukraine
NCT number | NCT03782935 |
Other study ID # | 080035 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2006 |
Est. completion date | June 2013 |
Verified date | December 2018 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Interventional study randomizing pregnant women at two sites in Ukraine who have or have not already consumed moderate to heavy levels of alcohol in pregnancy to receiving a standard prenatal vitamin supplement with or without additional choline supplement or standard of care (recommendation to take vitamin supplements) through the remainder of pregnancy, and to compare neurobehavioral performance of the offspring on the Bayley Scales of Infant Development at 12 months of age between groups. The overall sample size target was 300 alcohol exposed and 300 low or unexposed across both sites.
Status | Completed |
Enrollment | 600 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - currently pregnant - reported alcohol consumption 4-5 drinks per occasion on 3-4 occasions in the month around conception or the most recent month of pregnancy, or - no more than 2 drinks per occasion in either the month around conception or the most recent month of pregnancy Exclusion Criteria: - unable to provide consent - unable to provide information about alcohol consumption |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of California, San Diego | National Institute on Alcohol Abuse and Alcoholism (NIAAA), Omni-Net Ukraine |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bayley Scales of Infant Development II Mental Developmental Index | Scaled score range 50 to 150 with higher scores indicating better performance | approximately 12 months of age adjusted for preterm delivery | |
Primary | Bayley Scales of Infant Development III Psychomotor Developmental Index | Scaled score range 50 to 150 with higher scores indicating better performance | approximately 12 months of age adjusted for preterm delivery |
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