Birth WeightJiVitA-5NCT03921177
Micronutrient Supplementation Before and During 1st Pregnancy to Improve Birth Outcomes (JiVitA-5)
A study testing Multiple micronutrient supplement in people with Birth Weight and Miscarriage, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Bangladesh.
Trial summary
The purpose of this cluster-randomized trial is to evaluate the efficacy of daily, multiple micronutrient (MM) supplement versus identical placebo use among nulligravid, recently married women, starting preconceptionally through the 1st trimester of pregnancy, in reducing low birth weight and other adverse pregnancy… Read more about this study
- Who is it for?
- Ages Up to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth Weight, Miscarriage, Small-for-gestational Age
- What is being tested?
- Multiple micronutrient supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9,859 participants
- Where
- 1 siteBangladesh
- Study dates
- 17 Jan 2019to 29 May 2021
- 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 Up to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Resident of 566 rural sectors (clusters) in Gaibandha district
- Recently-married woman
- Nulligravid
Who cannot join
- Women with a history of previous pregnancy
- Women who refuse consent for participation
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this cluster-randomized trial is to evaluate the efficacy of daily, multiple micronutrient (MM) supplement versus identical placebo use among nulligravid, recently married women, starting preconceptionally through the 1st trimester of pregnancy, in reducing low birth weight and other adverse pregnancy outcomes in rural Bangladesh.
Read the detailed description
Micronutrient deficiencies are common among women of reproductive age in rural South Asia, including Bangladesh. Antenatal multiple micronutrient (MM) supplementation, usually starting toward the end of the 1st trimester, has been shown to reduce low birth weight in many cultures. In northern Bangladesh, where the current study will be conducted, MM versus iron-folic acid supplementation has been shown to extend gestational age, thereby reducing risks of preterm birth 15% and low birth weight by 12%, and reduce risk of stillbirth by 11% (West KP et al. JAMA 2014), and to reduce risk of micronutrient deficiencies (Schulze KJ et al J Nutr 2019). Since it is plausible that women of reproductive age conceive in a state of lower micronutrient nutriture, it remains unknown the degree to which MM supplementation, starting preconceptionally through the 1st trimester (covering the periconceptional and embryonic period) can benefit pregnancy outcome. Further, there is concern that newlywed, nulligravid women in rural South Asia are at high risk, and may be at particular health and pregnancy risks due to micronutrient deficiencies resulting from dietary inadequacy.
The investigators propose to conduct a double-masked, cluster-randomized, placebo-controlled trial among recently married women in 18 rural unions of Gaibandha District, Bangladesh, that will provide a daily tablet containing either (a) a MM formulation containing a US Institute of Medicine (IOM) Recommended Dietary Allowance (RDA) for pregnancy for 15 essential vitamins and minerals (and closely approximates the UNIMAP formula), or (b) a placebo tablet of identical appearance containing no micronutrients, during a period extending from at least one-month prior to last menstrual period through the 1st trimester of pregnancy (~12 weeks' gestation). The study area will comprise 566 rural clusters (sectors) each with 250-400 households, serving as units of randomization. Consenting, recently married women will be detected through routine community surveillance and start to receive coded, double-masked supplements, resupplied during monthly home visits. Participating women will receive coded supplements for daily consumption until the end of the trial or until determined to be pregnant. On detection of pregnancy by a history of amenorrhea confirmed by urine test, irrespective of randomized allocation, all women will be switched to receive an open-labeled MM supplement, expected to occur toward the end of the 1st trimester, which will continue through 3 months post-partum. This switch is in response to previous positive effects shown on pregnancy outcomes with a MM supplement starting at the end of the 1st trimester.
Participating married women will be periodically interviewed for socioeconomic, morbidity, dietary and lifestyle risk factors and assessed by anthropometry. Pregnancies will be followed for miscarriage, abortion, live birth and still birth outcomes. Newborn anthropometry will be assessed to determine birth weight and size. Infants and mothers will be eligible for additional breast feeding, dietary, morbidity and growth assessments at 8 days, and 1, 3 and 6 months after delivery. Participating women resident in a predefined subset of the study area (n~68 sectors) will receive enhanced assessments, including blood draw in the end of the 1st trimester for subsequent laboratory assessment of micronutrient status, and body composition, among other measures.
- Conditions
- Birth Weight, Miscarriage, Small-for-gestational Age, Preterm Birth
- Being tested
- Multiple micronutrient supplement, Placebo Oral Tablet
- Keywords
- preconceptional multiple micronutrient supplementation, periconceptional multiple micronutrient supplementation, pregnancy outcomes, adolescent pregnancy, Bangladesh
- Medical subject headings
- Birth Weight, Abortion, Spontaneous, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple micronutrient supplementDietary supplement
Preconception to 12-weeks gestation: daily (coded) multiple micronutrient supplement containing 15-nutrients (vitamins and minerals) providing an approximate recommended dietary allowance for pregnant women, approximating the UNICEF UNIMAP formulation (UN micronutrient preparation).
Placebo Oral TabletDrug
Preconception to 12-weeks gestation: identical tablet
| Study group | Role | What they receive |
|---|---|---|
| Multiple micronutrient supplement | Experimental | Daily micronutrient supplement Receives: Dietary Supplement: Multiple micronutrient supplement |
| Placebo | Placebo comparator | Daily identifcal placebo tablet Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preterm Birth - number of live-births occurring earlier than 37 weeks gestation among all live-births (with known gestational age)
Pregnancies ending in a live birth less than 37 weeks' gestation
Measured: up to 38 weeks of gestation
Miscarriage - number of spontaneous abortions occurring earlier than 24 weeks gestation among all pregnancies (with known gestational age)
Pregnancies ending as a spontaneous abortion less than 24 weeks' gestation
Measured: up to 24 weeks gestation
Small for Gestational Age - number of live-born neonates weighing less than the 10th centile of birth weight for gestational age and sex among all live-births (with known gestational age and birth weight)
Infants weighing less than the 10th centile of birth weight for gestational age and sex
Measured: up to 72 hours after live birth
Low Birth Weight - number of live-born neonates weighing less than 2500 g at birth among all live-births (with known birth weight)
Infants weighing less than 2500 g at birth
Measured: Measured from time of live birth through 72 hours after birth
Secondary outcomes (7)
Anemia in Pregnant Women
Hemoglobin in whole blood, less than a cutoff of 110 g/L
Measured: Measured at 12 weeks gestation
Iron Status
Distribution of plasma ferritin, ng/mL
Measured: Measured at 12 weeks gestation
Vitamin A Status
Distribution of plasma retinol, micromoles/L
Measured: Measured at 12 weeks gestation
Vitamin E Status
Distribution of plasma alpha-tocopherol, micromoles/L
Measured: Measured at 12 weeks gestation
Folate Status
Distribution of total plasma folate, nmol/L
Measured: Measured at 12 weeks gestation
Vitamin B12 Status
Distribution of total plasma cobalamin, pmol/L
Measured: Measured at 12 weeks gestation
Selenium Status
Distribution of total plasma selenium, ng/mL
Measured: Measured at 12 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start17 Jan 2019
- Primary completion30 Nov 2020
- Study completion29 May 2021
Why it stopped: Extended COVID-19 restrictions on field research and limited funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Birth WeightStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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
- Cluster-randomized, placebo-controlled concurrent intervention trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9,859 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- JiVitA Project, Gaibandha, Bangladesh
- Responsible party
- Sponsor
- Investigators
- Keith P West, Jr., DrPH, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921177
- Sponsor's protocol ID
- IRB 7841
- Acronym
- JiVitA-5
- Status last verified
- Jun 2021
- First submitted
- 11 Apr 2019
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To be delineated
Publications
West KP Jr, Shamim AA, Mehra S, Labrique AB, Ali H, Shaikh S, Klemm RD, Wu LS, Mitra M, Haque R, Hanif AA, Massie AB, Merrill RD, Schulze KJ, Christian P. Effect of maternal multiple micronutrient vs iron-folic acid supplementation on infant mortality and adverse birth outcomes in rural Bangladesh: the JiVitA-3 randomized trial. JAMA. 2014 Dec 24-31;312(24):2649-58. doi: 10.1001/jama.2014.16819.
PubMed 25536256Sugimoto JD, Labrique AB, Ahmad S, Rashid M, Klemm RD, Christian P, West KP Jr. Development and management of a geographic information system for health research in a developing-country setting: a case study from Bangladesh. J Health Popul Nutr. 2007 Dec;25(4):436-47.
PubMed 18402187Gernand AD, Schulze KJ, Stewart CP, West KP Jr, Christian P. Micronutrient deficiencies in pregnancy worldwide: health effects and prevention. Nat Rev Endocrinol. 2016 May;12(5):274-89. doi: 10.1038/nrendo.2016.37. Epub 2016 Apr 1.
PubMed 27032981Labrique AB, Christian P, Klemm RD, Rashid M, Shamim AA, Massie A, Schulze K, Hackman A, West KP Jr. A cluster-randomized, placebo-controlled, maternal vitamin A or beta-carotene supplementation trial in Bangladesh: design and methods. Trials. 2011 Apr 21;12:102. doi: 10.1186/1745-6215-12-102.
PubMed 21510905
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micronutrient Supplementation Before and During 1st Pregnancy to Improve Birth Outcomes (JiVitA-5)
- ClinicalTrials.gov ID
- NCT03921177
- Acronym / sponsor ID
- JiVitA-5 / IRB 7841
- Conditions
- Birth Weight, Miscarriage, Small-for-gestational Age, Preterm Birth
- Keywords
- preconceptional multiple micronutrient supplementation, periconceptional multiple micronutrient supplementation, pregnancy outcomes, adolescent pregnancy, Bangladesh
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Extended COVID-19 restrictions on field research and limited funding
- Enrolment
- 9,859 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- JiVitA Project, Gaibandha, Bangladesh
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 29 May 2021 (actual)
- First posted
- 19 Apr 2019 (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.
The purpose of this cluster-randomized trial is to evaluate the efficacy of daily, multiple micronutrient (MM) supplement versus identical placebo use among nulligravid, recently married women, starting preconceptionally through the 1st trimester of pregnancy, in reducing low birth weight and other adverse pregnancy outcomes in rural Bangladesh.
Detailed description
Micronutrient deficiencies are common among women of reproductive age in rural South Asia, including Bangladesh. Antenatal multiple micronutrient (MM) supplementation, usually starting toward the end of the 1st trimester, has been shown to reduce low birth weight in many cultures. In northern Bangladesh, where the current study will be conducted, MM versus iron-folic acid supplementation has been shown to extend gestational age, thereby reducing risks of preterm birth 15% and low birth weight by 12%, and reduce risk of stillbirth by 11% (West KP et al. JAMA 2014), and to reduce risk of micronutrient deficiencies (Schulze KJ et al J Nutr 2019). Since it is plausible that women of reproductive age conceive in a state of lower micronutrient nutriture, it remains unknown the degree to which MM supplementation, starting preconceptionally through the 1st trimester (covering the periconceptional and embryonic period) can benefit pregnancy outcome. Further, there is concern that newlywed, nulligravid women in rural South Asia are at high risk, and may be at particular health and pregnancy risks due to micronutrient deficiencies resulting from dietary inadequacy.
The investigators propose to conduct a double-masked, cluster-randomized, placebo-controlled trial among recently married women in 18 rural unions of Gaibandha District, Bangladesh, that will provide a daily tablet containing either (a) a MM formulation containing a US Institute of Medicine (IOM) Recommended Dietary Allowance (RDA) for pregnancy for 15 essential vitamins and minerals (and closely approximates the UNIMAP formula), or (b) a placebo tablet of identical appearance containing no micronutrients, during a period extending from at least one-month prior to last menstrual period through the 1st trimester of pregnancy (~12 weeks' gestation). The study area will comprise 566 rural clusters (sectors) each with 250-400 households, serving as units of randomization. Consenting, recently married women will be detected through routine community surveillance and start to receive coded, double-masked supplements, resupplied during monthly home visits. Participating women will receive coded supplements for daily consumption until the end of the trial or until determined to be pregnant. On detection of pregnancy by a history of amenorrhea confirmed by urine test, irrespective of randomized allocation, all women will be switched to receive an open-labeled MM supplement, expected to occur toward the end of the 1st trimester, which will continue through 3 months post-partum. This switch is in response to previous positive effects shown on pregnancy outcomes with a MM supplement starting at the end of the 1st trimester.
Participating married women will be periodically interviewed for socioeconomic, morbidity, dietary and lifestyle risk factors and assessed by anthropometry. Pregnancies will be followed for miscarriage, abortion, live birth and still birth outcomes. Newborn anthropometry will be assessed to determine birth weight and size. Infants and mothers will be eligible for additional breast feeding, dietary, morbidity and growth assessments at 8 days, and 1, 3 and 6 months after delivery. Participating women resident in a predefined subset of the study area (n~68 sectors) will receive enhanced assessments, including blood draw in the end of the 1st trimester for subsequent laboratory assessment of micronutrient status, and body composition, among other measures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster-randomized, placebo-controlled concurrent intervention trial
| Arm | Type | Receives |
|---|---|---|
| Multiple micronutrient supplement | Experimental | Dietary Supplement: Multiple micronutrient supplementDaily micronutrient supplement |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletDaily identifcal placebo tablet |
Who may qualify
- Ages
- Up to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Resident of 566 rural sectors (clusters) in Gaibandha district
- Recently-married woman
- Nulligravid
Key exclusion criteria (2 listed)
- Women with a history of previous pregnancy
- Women who refuse consent for participation
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 |
|---|---|---|
| Multiple micronutrient supplementPreconception to 12-weeks gestation: daily (coded) multiple micronutrient supplement containing 15-nutrients (vitamins and minerals) providing an approximate recommended dietary allowance for pregnant women, approximating the UNICEF UNIMAP formulation (UN micronutrient preparation). | Dietary supplement | Multiple micronutrient supplement |
| Placebo Oral TabletPreconception to 12-weeks gestation: identical tablet | Drug | Placebo |
Primary outcome
Preterm Birth - number of live-births occurring earlier than 37 weeks gestation among all live-births (with known gestational age)
Time frame: up to 38 weeks of gestation
Pregnancies ending in a live birth less than 37 weeks' gestation
Miscarriage - number of spontaneous abortions occurring earlier than 24 weeks gestation among all pregnancies (with known gestational age)
Time frame: up to 24 weeks gestation
Pregnancies ending as a spontaneous abortion less than 24 weeks' gestation
Small for Gestational Age - number of live-born neonates weighing less than the 10th centile of birth weight for gestational age and sex among all live-births (with known gestational age and birth weight)
Time frame: up to 72 hours after live birth
Infants weighing less than the 10th centile of birth weight for gestational age and sex
Low Birth Weight - number of live-born neonates weighing less than 2500 g at birth among all live-births (with known birth weight)
Time frame: Measured from time of live birth through 72 hours after birth
Infants weighing less than 2500 g at birth
7 secondary outcomes
Anemia in Pregnant Women
Time frame: Measured at 12 weeks gestation
Iron Status
Time frame: Measured at 12 weeks gestation
Vitamin A Status
Time frame: Measured at 12 weeks gestation
Vitamin E Status
Time frame: Measured at 12 weeks gestation
Folate Status
Time frame: Measured at 12 weeks gestation
Vitamin B12 Status
Time frame: Measured at 12 weeks gestation
Selenium Status
Time frame: Measured at 12 weeks gestation
Results and safety
The study was stopped early (reason given: Extended COVID-19 restrictions on field research and limited funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Background: PubMed 25536256West KP Jr, Shamim AA, Mehra S, Labrique AB, Ali H, Shaikh S, Klemm RD, Wu LS, Mitra M, Haque R, Hanif AA, Massie AB, Merrill RD, Schulze KJ, Christian P. Effect of maternal multiple micronutrient vs iron-folic acid supplementation on infant mortality and adverse birth outcomes in rural Bangladesh: the JiVitA-3 randomized trial. JAMA. 2014 Dec 24-31;312(24):2649-58. doi: 10.1001/jama.2014.16819.
- Background: PubMed 18402187Sugimoto JD, Labrique AB, Ahmad S, Rashid M, Klemm RD, Christian P, West KP Jr. Development and management of a geographic information system for health research in a developing-country setting: a case study from Bangladesh. J Health Popul Nutr. 2007 Dec;25(4):436-47.
- Background: PubMed 27032981Gernand AD, Schulze KJ, Stewart CP, West KP Jr, Christian P. Micronutrient deficiencies in pregnancy worldwide: health effects and prevention. Nat Rev Endocrinol. 2016 May;12(5):274-89. doi: 10.1038/nrendo.2016.37. Epub 2016 Apr 1.
- Background: PubMed 21510905Labrique AB, Christian P, Klemm RD, Rashid M, Shamim AA, Massie A, Schulze K, Hackman A, West KP Jr. A cluster-randomized, placebo-controlled, maternal vitamin A or beta-carotene supplementation trial in Bangladesh: design and methods. Trials. 2011 Apr 21;12:102. doi: 10.1186/1745-6215-12-102.
- Individual participant dataSharing planned: Yes. To be delineated
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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.
Keith P West, Jr., DrPH principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple micronutrient supplement in people with Birth Weight and Miscarriage, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Bangladesh.
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: stopped early, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Extended COVID-19 restrictions on field research and limited funding). Results are not available in the source record.
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?
Preterm Birth - number of live-births occurring earlier than 37 weeks gestation among all live-births (with known gestational age) (time frame: up to 38 weeks of gestation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03921177, which also lists 4 linked publications.
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 4 Jun 2021.