NCT03921177

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,859

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 19, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2021

Completed
Last Updated

June 4, 2021

Status Verified

June 1, 2021

Enrollment Period

1.9 years

First QC Date

April 11, 2019

Last Update Submit

June 1, 2021

Conditions

Birth WeightMiscarriageSmall-for-gestational AgePreterm Birth

Keywords

preconceptional multiple micronutrient supplementationpericonceptional multiple micronutrient supplementationpregnancy outcomesadolescent pregnancyBangladesh

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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

    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 from time of live birth through 72 hours after birth

Secondary Outcomes (7)

  • Anemia in Pregnant Women

    Measured at 12 weeks gestation

  • Iron Status

    Measured at 12 weeks gestation

  • Vitamin A Status

    Measured at 12 weeks gestation

  • Vitamin E Status

    Measured at 12 weeks gestation

  • Folate Status

    Measured at 12 weeks gestation

  • +2 more secondary outcomes

Study Arms (2)

Multiple micronutrient supplement

EXPERIMENTAL

Daily micronutrient supplement

Dietary Supplement: Multiple micronutrient supplement

Placebo

PLACEBO COMPARATOR

Daily identifcal placebo tablet

Drug: Placebo Oral Tablet

Interventions

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).

Multiple micronutrient supplement
Placebo Oral TabletDRUG

Preconception to 12-weeks gestation: identical tablet

Placebo

Eligibility Criteria

AgeUp to 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

JiVitA Project Office

Gaibandha, Gaibandha Distict, 5700, Bangladesh

Location

Related Publications (4)

  • 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.

    PMID: 25536256BACKGROUND

  • Sugimoto 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.

    PMID: 18402187BACKGROUND

  • Gernand 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.

    PMID: 27032981BACKGROUND

  • Labrique 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.

    PMID: 21510905BACKGROUND

MeSH Terms

Conditions

Birth WeightAbortion, SpontaneousPremature Birth

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesObstetric Labor, PrematureObstetric Labor Complications

Study Officials

  • Keith P West, Jr., DrPH

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Multiple micronutrient and placebo tablets are identical in size, shape, and appearance; coding of supplements carried out independent of investigators and research team.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster-randomized, placebo-controlled concurrent intervention trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2019

First Posted

April 19, 2019

Study Start

January 17, 2019

Primary Completion

November 30, 2020

Study Completion

May 29, 2021

Last Updated

June 4, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

To be delineated

Shared Documents
STUDY PROTOCOL
Time Frame
Not later than 4 years after completion of data collection in the field
Access Criteria
To be delineated

Locations

BA(1)