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Antenatal Micronutrient Supplementation and Infant Survival (JiVitA-3)

Primary Purpose

Infant Mortality, Preterm Birth, Low Birth Weight

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Iron (27 mg) - folic acid (600 ug)
Multiple micronutrient
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infant Mortality focused on measuring micronutrients, deficiency, pregnancy, birth outcomes, infant mortality, neonatal mortality, malnutrition, antenatal

Eligibility Criteria

12 Years - 45 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Pregnant and consents to participate

Exclusion Criteria:

  • Not interviewed for consent within 12 consecutive weeks after being ascertained as pregnant by urine testing

Sites / Locations

  • Johns Hopkins School of Public Health
  • JiVitA Project Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Iron (27 mg) and folic acid (600 ug)

Multiple micronutrient

Outcomes

Primary Outcome Measures

Infant Mortality Through 6 mo of Age
Infant Mortality to Age 6 months (180 days from birth)

Secondary Outcome Measures

Neonatal Mortality
Neonatal Mortality (28 days of life)
Post-neonatal Mortality
Risk of Post-neonatal Mortality (29th -180th day of life)
Still Birth Rates
Stillbirth (born >=24 weeks without breathing, crying, or moving limbs).
Preterm Birth
Being born before 37 weeks of gestation
Extremely Pre-term
Birth before 28 weeks gestation
Very Pre-term
Birth between 28 and 32 weeks of gestation
Moderate to Late Preterm
Birth between 32 and 37 weeks gestation
Low Birth Weight
Birth weight below 2500g
Small for Gestation Age
Small for Gestational Age defined as birth weight <10th percentile of a standard reference (Alexander GR, Himes JH, Kaufman RB, et al. Obstet Gynecol. 1996;87(2):163-68).

Full Information

First Posted
March 11, 2009
Last Updated
October 18, 2022
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Bill and Melinda Gates Foundation, United States Agency for International Development (USAID), Mahidol University, Johns Hopkins University, Beximco Pharmaceuticals Ltd., DSM Nutritional Products, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00860470
Brief Title
Antenatal Micronutrient Supplementation and Infant Survival
Acronym
JiVitA-3
Official Title
Antenatal Multiple Micronutrient Supplementation to Improve Infant Survival and Health in Bangladesh
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Bill and Melinda Gates Foundation, United States Agency for International Development (USAID), Mahidol University, Johns Hopkins University, Beximco Pharmaceuticals Ltd., DSM Nutritional Products, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this community-based randomized trial is to examine whether a daily antenatal and postnatal multiple micronutrient supplement given to women will enhance newborn and infant survival and health and other birth outcomes in a rural setting in northwestern Bangladesh.
Detailed Description
Maternal deficiency in multiple essential micronutrients is likely to be a major public health problem in low-income countries. Supplementing mothers with certain individual micronutrients has been shown to confer health benefits, although the evidence is not clear for multiple micronutrients. We aim to test, in a cluster-randomized, double-masked, controlled trial whether giving a daily multiple micronutrient supplement (similar in composition to the UNICEF antenatal supplement) will enhance infant survival and birth outcomes such as birth weight and gestational duration in a rural population in Bangladesh. Over the duration of 2-3 years a community-surveillance in the northwestern, rural Districts of Gaibandha and Southern Rangpur, the trial plans to identify and recruit 45,000 pregnant women based on 5-weekly histories of amenorrhea confirmed by urine-testing, and supplement them with either a multiple micronutrient supplement or an iron-folic acid supplement (as the standard of care control for pregnancy) and monitor pregnancy health, birth outcomes and vital status and health of liveborn infants through 6 months of age. In a ~3% sub-sample of mothers, additional measures of nutritional and health status will be evaluated in the 1st and 3rd trimesters of pregnancy, and at 3 months postpartum (with infants), that include anthropometric and body composition (bioelectrical impedance) assessment, collection of biospecimens (eg, phlebotomy and breast milk sampling for micronutrient and other analyte concentration determinations), and other clinical assessments. The trial will generate evidence from which to examine the safety and efficacy of an antenatal through postnatal maternal micronutrient supplement intervention in order to inform and guide antenatal nutrition policies and programs in South Asia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Mortality, Preterm Birth, Low Birth Weight, Neonatal Mortality, Perinatal Mortality
Keywords
micronutrients, deficiency, pregnancy, birth outcomes, infant mortality, neonatal mortality, malnutrition, antenatal

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44567 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Iron (27 mg) and folic acid (600 ug)
Arm Title
2
Arm Type
Experimental
Arm Description
Multiple micronutrient
Intervention Type
Dietary Supplement
Intervention Name(s)
Iron (27 mg) - folic acid (600 ug)
Other Intervention Name(s)
iron-folate
Intervention Description
Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
Intervention Type
Dietary Supplement
Intervention Name(s)
Multiple micronutrient
Other Intervention Name(s)
one-a-day multivitamin, antenatal micronutrient
Intervention Description
Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
Primary Outcome Measure Information:
Title
Infant Mortality Through 6 mo of Age
Description
Infant Mortality to Age 6 months (180 days from birth)
Time Frame
6-months post-birth
Secondary Outcome Measure Information:
Title
Neonatal Mortality
Description
Neonatal Mortality (28 days of life)
Time Frame
1 month post-birth
Title
Post-neonatal Mortality
Description
Risk of Post-neonatal Mortality (29th -180th day of life)
Time Frame
1-6 months post-birth
Title
Still Birth Rates
Description
Stillbirth (born >=24 weeks without breathing, crying, or moving limbs).
Time Frame
24 weeks gestation to delivery
Title
Preterm Birth
Description
Being born before 37 weeks of gestation
Time Frame
Up to 37 weeks of gestation
Title
Extremely Pre-term
Description
Birth before 28 weeks gestation
Time Frame
Up to 28 weeks of gestation
Title
Very Pre-term
Description
Birth between 28 and 32 weeks of gestation
Time Frame
Between 27 and 33 weeks of gestation
Title
Moderate to Late Preterm
Description
Birth between 32 and 37 weeks gestation
Time Frame
Between 31 and 38 weeks of gestation
Title
Low Birth Weight
Description
Birth weight below 2500g
Time Frame
Measured at delivery/birth
Title
Small for Gestation Age
Description
Small for Gestational Age defined as birth weight <10th percentile of a standard reference (Alexander GR, Himes JH, Kaufman RB, et al. Obstet Gynecol. 1996;87(2):163-68).
Time Frame
At delivery/birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pregnant and consents to participate Exclusion Criteria: Not interviewed for consent within 12 consecutive weeks after being ascertained as pregnant by urine testing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith P West, Jr.
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Parul Christian
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins School of Public Health
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
JiVitA Project Office
City
Rangpur
State/Province
Gaibandha District
Country
Bangladesh

12. IPD Sharing Statement

Citations:
PubMed Identifier
12637400
Citation
Christian P, Khatry SK, Katz J, Pradhan EK, LeClerq SC, Shrestha SR, Adhikari RK, Sommer A, West KP Jr. Effects of alternative maternal micronutrient supplements on low birth weight in rural Nepal: double blind randomised community trial. BMJ. 2003 Mar 15;326(7389):571. doi: 10.1136/bmj.326.7389.571.
Results Reference
background
PubMed Identifier
12771347
Citation
Christian P. Micronutrients and reproductive health issues: an international perspective. J Nutr. 2003 Jun;133(6):1969S-1973S. doi: 10.1093/jn/133.6.1969S.
Results Reference
background
PubMed Identifier
14608063
Citation
Christian P, Shrestha J, LeClerq SC, Khatry SK, Jiang T, Wagner T, Katz J, West KP Jr. Supplementation with micronutrients in addition to iron and folic acid does not further improve the hematologic status of pregnant women in rural Nepal. J Nutr. 2003 Nov;133(11):3492-8. doi: 10.1093/jn/133.11.3492.
Results Reference
background
PubMed Identifier
14668283
Citation
Christian P, West KP, Khatry SK, Leclerq SC, Pradhan EK, Katz J, Shrestha SR, Sommer A. Effects of maternal micronutrient supplementation on fetal loss and infant mortality: a cluster-randomized trial in Nepal. Am J Clin Nutr. 2003 Dec;78(6):1194-202. doi: 10.1093/ajcn/78.6.1194.
Results Reference
background
PubMed Identifier
14758431
Citation
Katz J, West KP Jr, Khatry SK, Christian P, LeClerq SC, Pradhan EK, Shrestha SR. Risk factors for early infant mortality in Sarlahi district, Nepal. Bull World Health Organ. 2003;81(10):717-25. Epub 2003 Nov 25.
Results Reference
background
PubMed Identifier
15867289
Citation
Jiang T, Christian P, Khatry SK, Wu L, West KP Jr. Micronutrient deficiencies in early pregnancy are common, concurrent, and vary by season among rural Nepali pregnant women. J Nutr. 2005 May;135(5):1106-12. doi: 10.1093/jn/135.5.1106.
Results Reference
background
PubMed Identifier
16125578
Citation
Christian P, Osrin D, Manandhar DS, Khatry SK, de L Costello AM, West KP Jr. Antenatal micronutrient supplements in Nepal. Lancet. 2005 Aug 27-Sep 2;366(9487):711-2. doi: 10.1016/S0140-6736(05)67166-8. No abstract available.
Results Reference
background
PubMed Identifier
16600929
Citation
Christian P, Jiang T, Khatry SK, LeClerq SC, Shrestha SR, West KP Jr. Antenatal supplementation with micronutrients and biochemical indicators of status and subclinical infection in rural Nepal. Am J Clin Nutr. 2006 Apr;83(4):788-94. doi: 10.1093/ajcn/83.4.788.
Results Reference
background
PubMed Identifier
16614435
Citation
Katz J, Christian P, Dominici F, Zeger SL. Treatment effects of maternal micronutrient supplementation vary by percentiles of the birth weight distribution in rural Nepal. J Nutr. 2006 May;136(5):1389-94. doi: 10.1093/jn/136.5.1389.
Results Reference
background
PubMed Identifier
18262025
Citation
West KP Jr, Christian P. Antenatal micronutrients in undernourished people. Lancet. 2008 Feb 9;371(9611):452-4. doi: 10.1016/S0140-6736(08)60214-7. No abstract available.
Results Reference
background
PubMed Identifier
18644934
Citation
Christian P, Darmstadt GL, Wu L, Khatry SK, Leclerq SC, Katz J, West KP Jr, Adhikari RK. The effect of maternal micronutrient supplementation on early neonatal morbidity in rural Nepal: a randomised, controlled, community trial. Arch Dis Child. 2008 Aug;93(8):660-4. doi: 10.1136/adc.2006.114009.
Results Reference
background
PubMed Identifier
11304051
Citation
Shankar AH, Genton B, Baisor M, Paino J, Tamja S, Adiguma T, Wu L, Rare L, Bannon D, Tielsch JM, West KP Jr, Alpers MP. The influence of zinc supplementation on morbidity due to Plasmodium falciparum: a randomized trial in preschool children in Papua New Guinea. Am J Trop Med Hyg. 2000 Jun;62(6):663-9. doi: 10.4269/ajtmh.2000.62.663.
Results Reference
background
PubMed Identifier
35155983
Citation
Smith JW, Matchado AJ, Wu LS, Arnold CD, Burke SM, Maleta KM, Ashorn P, Stewart CP, Shaikh S, Ali H, Labrique AB, West KP Jr, Christian P, Dewey KG, Groopman JD, Schulze KJ. Longitudinal Assessment of Prenatal, Perinatal, and Early-Life Aflatoxin B1 Exposure in 828 Mother-Child Dyads from Bangladesh and Malawi. Curr Dev Nutr. 2022 Jan 7;6(2):nzab153. doi: 10.1093/cdn/nzab153. eCollection 2022 Feb.
Results Reference
derived
PubMed Identifier
32844185
Citation
Schulze KJ, Gernand AD, Khan AZ, Wu LS, Mehra S, Shaikh S, Ali H, Shamim AA, Sungpuag P, Udomkesmalee E, Labrique AB, West KP, Christian P. Newborn micronutrient status biomarkers in a cluster-randomized trial of antenatal multiple micronutrient compared with iron folic acid supplementation in rural Bangladesh. Am J Clin Nutr. 2020 Nov 11;112(5):1328-1337. doi: 10.1093/ajcn/nqaa223.
Results Reference
derived
PubMed Identifier
31006806
Citation
Schulze KJ, Mehra S, Shaikh S, Ali H, Shamim AA, Wu LS, Mitra M, Arguello MA, Kmush B, Sungpuag P, Udomkesmelee E, Merrill R, Klemm RDW, Ullah B, Labrique AB, West KP, Christian P. Antenatal Multiple Micronutrient Supplementation Compared to Iron-Folic Acid Affects Micronutrient Status but Does Not Eliminate Deficiencies in a Randomized Controlled Trial Among Pregnant Women of Rural Bangladesh. J Nutr. 2019 Jul 1;149(7):1260-1270. doi: 10.1093/jn/nxz046.
Results Reference
derived
PubMed Identifier
27769295
Citation
Gernand AD, Paul RR, Ullah B, Taher MA, Witter FR, Wu L, Labrique AB, West KP Jr, Christian P. A home calendar and recall method of last menstrual period for estimating gestational age in rural Bangladesh: a validation study. J Health Popul Nutr. 2016 Oct 21;35(1):34. doi: 10.1186/s41043-016-0072-y.
Results Reference
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PubMed Identifier
27604769
Citation
Christian P, Kim J, Mehra S, Shaikh S, Ali H, Shamim AA, Wu L, Klemm R, Labrique AB, West KP Jr. Effects of prenatal multiple micronutrient supplementation on growth and cognition through 2 y of age in rural Bangladesh: the JiVitA-3 Trial. Am J Clin Nutr. 2016 Oct;104(4):1175-1182. doi: 10.3945/ajcn.116.135178. Epub 2016 Sep 7.
Results Reference
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PubMed Identifier
26431336
Citation
Gernand AD, Schulze KJ, Nanayakkara-Bind A, Arguello M, Shamim AA, Ali H, Wu L, West KP Jr, Christian P. Effects of Prenatal Multiple Micronutrient Supplementation on Fetal Growth Factors: A Cluster-Randomized, Controlled Trial in Rural Bangladesh. PLoS One. 2015 Oct 2;10(10):e0137269. doi: 10.1371/journal.pone.0137269. eCollection 2015.
Results Reference
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PubMed Identifier
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Citation
Heaney CD, Kmush B, Navas-Acien A, Francesconi K, Gossler W, Schulze K, Fairweather D, Mehra S, Nelson KE, Klein SL, Li W, Ali H, Shaikh S, Merrill RD, Wu L, West KP Jr, Christian P, Labrique AB. Arsenic exposure and hepatitis E virus infection during pregnancy. Environ Res. 2015 Oct;142:273-80. doi: 10.1016/j.envres.2015.07.004. Epub 2015 Jul 15.
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PubMed Identifier
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Citation
Sikder SS, Labrique AB, Craig IM, Wakil MA, Shamim AA, Ali H, Mehra S, Wu L, Shaikh S, West KP Jr, Christian P. Patterns and determinants of care seeking for obstetric complications in rural northwest Bangladesh: analysis from a prospective cohort study. BMC Health Serv Res. 2015 Apr 18;15:166. doi: 10.1186/s12913-015-0832-1.
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PubMed Identifier
25536256
Citation
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.
Results Reference
derived
Links:
URL
http://www.jhsph.edu/chn/research/jivita1.html
Description
Basic description of the JiVitA project, location and individuals

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Antenatal Micronutrient Supplementation and Infant Survival

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