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Nutritional Risk Factors for FASD in Ukraine

NCT ID: NCT03782935

Last Updated: 2018-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fetal Alcohol Spectrum Disorders

Keywords

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alcohol pregnancy infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Prenatal multivitamin mineral supplement

Intervention Type DIETARY_SUPPLEMENT

prenatal vitamin/mineral supplement with or without choline supplement

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

Group Type EXPERIMENTAL

Prenatal multivitamin mineral supplement

Intervention Type DIETARY_SUPPLEMENT

prenatal vitamin/mineral supplement with or without choline supplement

Comparison

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prenatal multivitamin mineral supplement

prenatal vitamin/mineral supplement with or without choline supplement

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Prenatal multivitamin mineral supplement plus choline supplement

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Omni-Net Ukraine

UNKNOWN

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Christina Chambers

Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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080035

Identifier Type: -

Identifier Source: org_study_id