Antenatal Micronutrient Supplementation and Infant Survival

NCT00860470 | Completed Phase 3 Results DMC

• 1 other identifier: JHU_IRB 570
• Study Type: interventional
• Target: 44,567
• Locations: 2 countries
• Sites: 2

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.

Conditions

Infant Mortality; Preterm Birth; Low Birth Weight; Neonatal Mortality; Perinatal Mortality

Keywords

micronutrients; deficiency; pregnancy; birth outcomes; infant mortality; neonatal mortality; malnutrition; antenatal

Outcome Measures

Primary Outcomes (1)

• Infant Mortality Through 6 mo of Age

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

  6-months post-birth

Secondary Outcomes (9)

• Neonatal Mortality

  1 month post-birth

• Post-neonatal Mortality

  1-6 months post-birth

• Still Birth Rates

  24 weeks gestation to delivery

• Preterm Birth

  Up to 37 weeks of gestation

• Extremely Pre-term

  Up to 28 weeks of gestation

Study Arms (2)

1

ACTIVE COMPARATOR

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

Dietary Supplement: Iron (27 mg) - folic acid (600 ug)

2

EXPERIMENTAL

Multiple micronutrient

Dietary Supplement: Multiple micronutrient

Interventions

Iron (27 mg) - folic acid (600 ug) DIETARY_SUPPLEMENT

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.

Also known as: iron-folate

1

Multiple micronutrient DIETARY_SUPPLEMENT

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.

Also known as: one-a-day multivitamin, antenatal micronutrient

2

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant and consents to participate

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Bill and Melinda Gates Foundation: collaborator
• United States Agency for International Development (USAID): collaborator
• Mahidol University: collaborator
• Johns Hopkins University: collaborator
• Beximco Pharmaceuticals Ltd.: collaborator
• DSM Nutritional Products, Inc.: collaborator

Study Sites (2)

Johns Hopkins School of Public Health

Baltimore, Maryland, 21205, United States

Location

JiVitA Project Office

Rangpur City, Gaibandha District, Bangladesh

Location

Related Publications (23)

• 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.

  PMID: 12637400 BACKGROUND

• 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.

  PMID: 12771347 BACKGROUND

• 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.

  PMID: 14608063 BACKGROUND

• 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.

  PMID: 14668283 BACKGROUND

• 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.

  PMID: 14758431 BACKGROUND

• 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.

  PMID: 15867289 BACKGROUND

• 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.

  PMID: 16125578 BACKGROUND

• 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.

  PMID: 16600929 BACKGROUND

• 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.

  PMID: 16614435 BACKGROUND

• 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.

  PMID: 18262025 BACKGROUND

• 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.

  PMID: 18644934 BACKGROUND

• 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.

  PMID: 11304051 BACKGROUND

• de Boer M, Thorne-Lyman AL, Shamim AA, Wu LS, Shaikh S, Ali H, West KP, Christian P. Dietary diversity as a modifier of the effect of supplementation with multiple micronutrients during pregnancy on low birth weight in a randomized controlled trial in Bangladesh. Am J Clin Nutr. 2025 Sep;122(3):762-769. doi: 10.1016/j.ajcnut.2025.07.007. Epub 2025 Jul 12.

  PMID: 40653272 DERIVED

• Finkelstein JL, Cuthbert A, Weeks J, Venkatramanan S, Larvie DY, De-Regil LM, Garcia-Casal MN. Daily oral iron supplementation during pregnancy. Cochrane Database Syst Rev. 2024 Aug 15;8(8):CD004736. doi: 10.1002/14651858.CD004736.pub6.

  PMID: 39145520 DERIVED

• 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.

  PMID: 35155983 DERIVED

• 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.

  PMID: 32844185 DERIVED

• 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.

  PMID: 31006806 DERIVED

• 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.

  PMID: 27769295 DERIVED

• 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.

  PMID: 27604769 DERIVED

• 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.

  PMID: 26431336 DERIVED

• 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.

  PMID: 26186135 DERIVED

• 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.

  PMID: 25985774 DERIVED

• 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: 25536256 DERIVED

Related Links

• Basic description of the JiVitA project, location and individuals

MeSH Terms

Conditions

Infant Death; Premature Birth; Perinatal Death; Malnutrition

Interventions

Iron; Folic Acid

Condition Hierarchy (Ancestors)

Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

The study was run in an area where iron deficiency rates were low.

Results Point of Contact

• Title: Keith P. West, Jr.
• Organization: JHSPH

kwest@jhsph.edu

4109552061

Study Officials

• Keith P West, Jr.

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

• Parul Christian

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2009
• First Posted: March 12, 2009
• Study Start: January 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 19, 2022
• Results First Posted: May 27, 2015

Record last verified: 2022-10

Locations

US (1); BA (1)