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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
| United States Agency for International Development (USAID) | FED |
| Mahidol University | OTHER |
| Johns Hopkins University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Iron (27 mg) and folic acid (600 ug) |
|
| 2 | Experimental | Multiple micronutrient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Infant Mortality Through 6 mo of Age | Infant Mortality to Age 6 months (180 days from birth) | 6-months post-birth |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Mortality | Neonatal Mortality (28 days of life) | 1 month post-birth |
| Post-neonatal Mortality | Risk of Post-neonatal Mortality (29th -180th day of life) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith P West, Jr. | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Parul Christian | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins School of Public Health | Baltimore | Maryland | 21205 | United States | ||
| JiVitA Project Office |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12637400 | Background | 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. | |
| 12771347 | Background |
| Label | URL |
|---|---|
| Basic description of the JiVitA project, location and individuals | View source |
Not provided
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Enumeration of women began in December 2007, and active recruitment of pregnant women into the trail began in January 2008. Women were enrolled into the trial by community workers from the projects who visited them at home.
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| ID | Title | Description |
|---|---|---|
| FG000 | Iron and Folate | Iron (27 mg) and folic acid (600 ug) Iron (27 mg) - folic acid (600 ug): 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. |
| FG001 | Multiple Micronutrient | Multiple micronutrient: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Iron and Folate | Iron (27 mg) and folic acid (600 ug) Iron (27 mg) - folic acid (600 ug): 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Infant Mortality Through 6 mo of Age | Infant Mortality to Age 6 months (180 days from birth) | Not all women recruited into the trial had pregnancies yielding live births. This represents all live births by arm. | Posted | Number | participants | 6-months post-birth |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Iron (27 mg) and Folic Acid (600 ug) | Iron (27 mg) and folic acid (600 ug) Iron (27 mg) - folic acid (600 ug): 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. |
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The study was run in an area where iron deficiency rates were low.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keith P. West, Jr. | JHSPH | 4109552061 | kwest@jhsph.edu |
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| ID | Term |
|---|---|
| D066088 | Infant Death |
| D047928 | Premature Birth |
| D066087 | Perinatal Death |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
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| ID | Term |
|---|---|
| D007501 | Iron |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
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| OTHER |
| Beximco Pharmaceuticals Ltd. | INDUSTRY |
| dsm-firmenich Switzerland AG | INDUSTRY |
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|
| 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. |
|
|
| 1-6 months post-birth |
| Still Birth Rates | Stillbirth (born >=24 weeks without breathing, crying, or moving limbs). | 24 weeks gestation to delivery |
| Preterm Birth | Being born before 37 weeks of gestation | Up to 37 weeks of gestation |
| Extremely Pre-term | Birth before 28 weeks gestation | Up to 28 weeks of gestation |
| Very Pre-term | Birth between 28 and 32 weeks of gestation | Between 27 and 33 weeks of gestation |
| Moderate to Late Preterm | Birth between 32 and 37 weeks gestation | Between 31 and 38 weeks of gestation |
| Low Birth Weight | Birth weight below 2500g | Measured at delivery/birth |
| 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). | At delivery/birth |
| Rangpur City |
| Gaibandha District |
| Bangladesh |
| 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. |
| 14608063 | 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. |
| 14668283 | 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. |
| 14758431 | 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. |
| 15867289 | 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. |
| 16125578 | 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. |
| 16600929 | 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. |
| 16614435 | 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. |
| 18262025 | 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. |
| 18644934 | 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. |
| 11304051 | 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. |
| 40653272 | Derived | 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. |
| 39145520 | 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. |
| 39062451 | Derived | Kim H, Bedsaul-Fryer JR, Schulze KJ, Sincerbeaux G, Baker S, Rebholz CM, Wu LS, Gogain J, Cuddeback L, Yager JD, De Luca LM, Siddiqua TJ, West KP Jr. An Early Gestation Plasma Inflammasome in Rural Bangladeshi Women. Biomolecules. 2024 Jun 21;14(7):736. doi: 10.3390/biom14070736. |
| 35155983 | 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. |
| 32844185 | 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. |
| 31006806 | 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. |
| 27769295 | 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. |
| 27604769 | 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. |
| 26431336 | 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. |
| 26186135 | 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. |
| 25985774 | 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. |
| 25536256 | 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. |
| Lost to Follow-up |
|
| Multiple Micronutrient |
Multiple micronutrient Multiple micronutrient: 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Gestational Age in weeks | Mean | Standard Deviation | weeks |
|
| Literacy | Number | participants |
|
| Parity | Reported for participants for whom baseline data for parity was available | Number | participants with reported data |
|
| Previous Pregnancy Loss | Number | participants |
|
|
|
|
| Secondary | Neonatal Mortality | Neonatal Mortality (28 days of life) | Posted | Number | participants | 1 month post-birth |
|
|
|
|
| Secondary | Post-neonatal Mortality | Risk of Post-neonatal Mortality (29th -180th day of life) | Posted | Number | participants | 1-6 months post-birth |
|
|
|
|
| Secondary | Still Birth Rates | Stillbirth (born >=24 weeks without breathing, crying, or moving limbs). | Posted | Number | participants | 24 weeks gestation to delivery |
|
|
|
|
| Secondary | Preterm Birth | Being born before 37 weeks of gestation | Posted | Number | participants | Up to 37 weeks of gestation |
|
|
|
|
| Secondary | Extremely Pre-term | Birth before 28 weeks gestation | Posted | Number | participants | Up to 28 weeks of gestation |
|
|
|
|
| Secondary | Very Pre-term | Birth between 28 and 32 weeks of gestation | Posted | Number | participants | Between 27 and 33 weeks of gestation |
|
|
|
|
| Secondary | Moderate to Late Preterm | Birth between 32 and 37 weeks gestation | Posted | Number | participants | Between 31 and 38 weeks of gestation |
|
|
|
|
| Secondary | Low Birth Weight | Birth weight below 2500g | Posted | Number | participants | Measured at delivery/birth |
|
|
|
|
| Secondary | 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). | Posted | Number | participants | At delivery/birth |
|
|
|
|
| 0 |
| 22,114 |
| 0 |
| 22,114 |
| EG001 | Multiple Micronutrient | Multiple micronutrient Multiple micronutrient: 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. | 0 | 22,346 | 0 | 22,346 |
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| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D008670 |
| Metals |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |