Fetal Alcohol Spectrum DisordersNCT03782935
Nutritional Risk Factors for FASD in Ukraine
A study testing Prenatal multivitamin mineral supplement in people with Fetal Alcohol Spectrum Disorders, run by University of California, San Diego.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fetal Alcohol Spectrum Disorders
- What is being tested?
- Prenatal multivitamin mineral supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- unable to provide consent
- unable to provide information about alcohol consumption
About this study
Official title: 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.
Read the 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
- 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
- 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
- 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
- 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
- Fetal Alcohol Spectrum Disorders
- Being tested
- Prenatal multivitamin mineral supplement
- Keywords
- alcohol, pregnancy, infant
- Medical subject headings
- Fetal Alcohol Spectrum Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prenatal multivitamin mineral supplementDietary supplement
Also called Prenatal multivitamin mineral supplement plus choline supplement
prenatal vitamin/mineral supplement with or without choline supplement
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bayley Scales of Infant Development II Mental Developmental Index
Scaled score range 50 to 150 with higher scores indicating better performance
Measured: 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
Measured: approximately 12 months of age adjusted for preterm delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study startJun 2006
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Alcohol Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Omni-Net Ukraine
- Responsible party
- Principal investigator, Christina Chambers, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782935
- Sponsor's protocol ID
- 080035
- Status last verified
- Dec 2018
- First submitted
- 18 Dec 2018
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Identification of Affected Children and Nutritional Risk Factors for FASD in Ukraine
- ClinicalTrials.gov ID
- NCT03782935
- Acronym / sponsor ID
- 080035
- Conditions
- Fetal Alcohol Spectrum Disorders
- Keywords
- alcohol, pregnancy, infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Omni-Net Ukraine
- Study start
- Jun 2006
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- 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
- 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
- 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
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| prenatal multivitamin mineral supplement | Experimental | Dietary Supplement: Prenatal multivitamin mineral supplementreceived 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 |
| prenatal multivitamin mineral supplement plus choline | Experimental | Dietary Supplement: Prenatal multivitamin mineral supplementreceived 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 |
| Comparison | No intervention | –Advised to follow obstetrics standard of care which is to take a prenatal vitamin/mineral supplement |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- unable to provide consent
- unable to provide information about alcohol consumption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prenatal multivitamin mineral supplementAlso: Prenatal multivitamin mineral supplement plus choline supplementprenatal vitamin/mineral supplement with or without choline supplement | Dietary supplement | prenatal multivitamin mineral supplement, prenatal multivitamin mineral supplement plus choline |
Primary outcome
Bayley Scales of Infant Development II Mental Developmental Index
Time frame: approximately 12 months of age adjusted for preterm delivery
Scaled score range 50 to 150 with higher scores indicating better performance
Bayley Scales of Infant Development III Psychomotor Developmental Index
Time frame: approximately 12 months of age adjusted for preterm delivery
Scaled score range 50 to 150 with higher scores indicating better performance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2018.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Prenatal multivitamin mineral supplement in people with Fetal Alcohol Spectrum Disorders, run by University of California, San Diego.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bayley Scales of Infant Development II Mental Developmental Index (time frame: approximately 12 months of age adjusted for preterm delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2018.