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Micronutrient Supplementation Before and During 1st Pregnancy to Improve Birth Outcomes (JiVitA-5) (JiVitA-5)

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ClinicalTrials.gov Identifier: NCT03921177
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Sponsor:
Collaborator:
JiVitA Project, Gaibandha, Bangladesh
Information provided by (Responsible Party):
Keith P. West, Johns Hopkins Bloomberg School of Public Health

Brief 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 outcomes in rural Bangladesh.

Condition or disease Intervention/treatment Phase
Birth Weight Miscarriage Small-for-gestational Age Preterm Birth Dietary Supplement: Multiple micronutrient supplement Drug: Placebo Oral Tablet Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18742 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster-randomized, placebo-controlled concurrent intervention trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Multiple micronutrient and placebo tablets are identical in size, shape, and appearance; coding of supplements carried out independent of investigators and research team.
Primary Purpose: Prevention
Official Title: Micronutrient Supplementation Before and During 1st Pregnancy to Improve Birth Outcomes (JiVitA-5)
Actual Study Start Date : January 17, 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Multiple micronutrient supplement
Daily micronutrient supplement
Dietary Supplement: Multiple micronutrient 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 Comparator: Placebo
Daily identifcal placebo tablet
Drug: Placebo Oral Tablet
Preconception to 12-weeks gestation: identical tablet




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. Anemia in Pregnant Women [ Time Frame: Measured at 12 weeks gestation ]
    Hemoglobin in whole blood, less than a cutoff of 110 g/L

  2. Iron Status [ Time Frame: Measured at 12 weeks gestation ]
    Distribution of plasma ferritin, ng/mL

  3. Vitamin A Status [ Time Frame: Measured at 12 weeks gestation ]
    Distribution of plasma retinol, micromoles/L

  4. Vitamin E Status [ Time Frame: Measured at 12 weeks gestation ]
    Distribution of plasma alpha-tocopherol, micromoles/L

  5. Folate Status [ Time Frame: Measured at 12 weeks gestation ]
    Distribution of total plasma folate, nmol/L

  6. Vitamin B12 Status [ Time Frame: Measured at 12 weeks gestation ]
    Distribution of total plasma cobalamin, pmol/L

  7. Selenium Status [ Time Frame: Measured at 12 weeks gestation ]
    Distribution of total plasma selenium, ng/mL



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Resident of 566 rural sectors (clusters) in Gaibandha district
  • Recently-married woman
  • Nulligravid

Exclusion Criteria:

  • Women with a history of previous pregnancy
  • Women who refuse consent for participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921177


Contacts
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Contact: Keith P West, Jr., DrPH 410-955-2061 kwest@jhu.edu

Locations
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United States, Maryland
Johns Hopkins School of Public Health Recruiting
Baltimore, Maryland, United States, 21205
Contact: Keith P West, Jr., DrPH    410-955-2061    kwest@jhu.edu   
Bangladesh
JiVitA Project Office Recruiting
Gaibandha, Gaibandha Distict, Bangladesh, 5700
Contact: Hasmot Ali, MBBS, MPH    +88 0541-62469    hasmot.jivita@gmail.com   
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
JiVitA Project, Gaibandha, Bangladesh

Publications:
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Responsible Party: Keith P. West, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT03921177     History of Changes
Other Study ID Numbers: IRB 7841
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: To be delineated
Supporting Materials: Study Protocol
Time Frame: Not later than 4 years after completion of data collection in the field
Access Criteria: To be delineated

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Keith P. West, Johns Hopkins Bloomberg School of Public Health:
preconceptional multiple micronutrient supplementation
periconceptional multiple micronutrient supplementation
pregnancy outcomes
adolescent pregnancy
Bangladesh

Additional relevant MeSH terms:
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Birth Weight
Premature Birth
Abortion, Spontaneous
Body Weight
Signs and Symptoms
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Micronutrients
Trace Elements
Nutrients
Growth Substances
Physiological Effects of Drugs