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Nutritional Risk Factors for FASD in Ukraine

NCT03782935 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2018-12-20

No results posted yet for this study

Summary

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.

Conditions

  • Fetal Alcohol Spectrum Disorders

Interventions

DIETARY_SUPPLEMENT

Prenatal multivitamin mineral supplement

prenatal vitamin/mineral supplement with or without choline supplement

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2013-06-30
Completion
2013-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03782935 on ClinicalTrials.gov