Nutritional Risk Factors for FASD in Ukraine

NCT03782935 | Completed DMC

• 1 other identifier: 080035
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

alcohol; pregnancy; infant

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

prenatal multivitamin mineral supplement

EXPERIMENTAL

received prenatal multivitamin mineral supplement at time of enrollment TheraVit multivitamin/mineral prenatal supplement with instructions to take 1 per day through the remainder of pregnancy

Dietary Supplement: Prenatal multivitamin mineral supplement

prenatal multivitamin mineral supplement plus choline

EXPERIMENTAL

received prenatal multivitamin mineral supplement plus additional choline supplemental vitamin TheraVit multivitamin mineral supplement plus 750 mg. choline with instructions to take1 multivitamin mineral supplement and 750 mg. per day of choline through the remainder of pregnancy

Dietary Supplement: Prenatal multivitamin mineral supplement

Comparison

NO INTERVENTION

Advised to follow obstetrics standard of care which is to take a prenatal vitamin/mineral supplement

Interventions

Prenatal multivitamin mineral supplement DIETARY_SUPPLEMENT

prenatal vitamin/mineral supplement with or without choline supplement

Also known as: Prenatal multivitamin mineral supplement plus choline supplement

prenatal multivitamin mineral supplement; prenatal multivitamin mineral supplement plus choline

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• unable to provide consent
• unable to provide information about alcohol consumption

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• Omni-Net Ukraine: collaborator

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: Pregnant women assigned to 1) over-the-counter approved prenatal multivitamin mineral supplement alone provided by the study at time of enrollment, 2)over-the-counter approved prenatal multivitamin mineral supplement with additional over-the-counter approved 750 mg choline supplement provided by the study at the time of enrollment, or 3) standard of care which is recommendation to take over-the-counter prenatal multivitamin mineral supplements

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 20, 2018
• Study Start: June 1, 2006
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 20, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2020 and indefinitely
• Access Criteria: Application to Collaborative Initiative on Fetal Alcohol Spectrum Disorders data oversight group at CIFASD.org