Nutritional Risk Factors for FASD in Ukraine

Early Identification of Affected Children and Nutritional Risk Factors for FASD in Ukraine

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.

Study Overview

• Status: Completed
• Conditions: Fetal Alcohol Spectrum Disorders
• Intervention / Treatment: Dietary supplement: Prenatal multivitamin mineral supplement

Detailed Description

Pregnant women coming in for routine prenatal diagnostic testing or prenatal care at two sites in Ukraine, Rivne Diagnostic Center or Khmelnytsky Regional Perinatal Center, were screened for alcohol consumption during pregnancy. Those who met the criteria of consuming 4-5 drinks per occasion on 3-4 occasions in either the month around conception or the most recent month of pregnancy were eligible for recruitment into the alcohol exposed group, and the next available woman who consumed no more than 2 drinks on any occasion in the month around conception or the most recent month of pregnancy was eligible for recruitment into the alcohol low or no exposure group. Within alcohol group and within site, women were randomized on a 1:1 basis to receiving a study-provided prenatal vitamin (TheraVit) manufactured in the U.S. and registered in Ukraine as an over-the-counter product, or to receiving standard of care which is obstetric advice to take prenatal vitamins on their own. Within the group randomized to receiving the prenatal vitamins, women were further randomized on a 1:1 basis to receiving an additional 750 mg. of supplemental choline manufactured in the U.S., and registered in Ukraine as an over-the-counter product.

Women in both cohorts were followed until delivery and those with live born children were followed until the child reached one year of age. The primary endpoint for the intervention was performance on the mental developmental index (MDI) and the psychomotor developmental index (PDI) components of the Bayley Scales of Infant Development II. The Bayley tests were administered at approximately 12 months adjusted chronological age by trained psychologists in Ukraine.

The primary comparison for the study was within the alcohol-exposed group, comparing mean Bayley scores on MDI and separately on PDI between those randomized to receiving the study prenatal vitamin and those randomized to standard of care.

Secondary comparisons for the study examined

1. the mean MDI and PDI scores on the Bayley within the alcohol-exposed group in those randomized to receiving the prenatal vitamin plus choline vs. those who received the prenatal vitamin alone
2. the mean MDI and PDI scores on the Bayley within the low or unexposed group in those who received the prenatal vitamin vs. those who did not
3. the mean MDI and PDI scores on the Bayley within the low or unexposed group in those who received the prenatal vitamin plus choline vs. those who received the prenatal vitamin alone
4. adjusted comparisons for all of the above taking into account participants who were taking vitamins on their own at the time of enrollment, and/or who were taking vitamins on their own if assigned to the standard of care group.

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: prenatal multivitamin mineral supplement; 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 vitamin/mineral supplement with or without choline supplement; Other Names: Prenatal multivitamin mineral supplement plus choline supplement
Experimental: prenatal multivitamin mineral supplement plus choline; 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; prenatal vitamin/mineral supplement with or without choline supplement; Other Names: Prenatal multivitamin mineral supplement plus choline supplement
No Intervention: Comparison; Advised to follow obstetrics standard of care which is to take a prenatal vitamin/mineral supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: December 18, 2018
• First Submitted That Met QC Criteria: December 19, 2018
• First Posted (Actual): December 20, 2018

Study Record Updates

• Last Update Posted (Actual): December 20, 2018
• Last Update Submitted That Met QC Criteria: December 19, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: pregnancy; alcohol; infant
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Fetal Diseases; Pregnancy Complications; Alcohol-Induced Disorders; Fetal Alcohol Spectrum Disorders; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Gastrointestinal Agents; Hypolipidemic Agents; Lipid Regulating Agents; Nootropic Agents; Lipotropic Agents; Choline
• Other Study ID Numbers: 080035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This study is part of a collaborative initiative on Fetal Alcohol Spectrum Disorders and de-identified data is available to share with other researchers on a specified timetable with appropriate application for use.
• IPD Sharing Time Frame: 2020 and indefinitely
• IPD Sharing Access Criteria: Application to Collaborative Initiative on Fetal Alcohol Spectrum Disorders data oversight group at CIFASD.org
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF