Micronutrient dose response (MiNDR) study among women of reproductive age and pregnant women in rural Bangladesh: study protocol for double-blind, randomised, controlled trials
Introduction Optimising the micronutrient status of women before and during reproduction confers benefits to them and their offspring. Antenatal multiple micronutrient supplements (MMS), given as a daily tablet with nutrients at ~1 recommended dietary allowance (RDA) or adequate intake (AI) reduces...
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| author | Tahmeed Ahmed Hasmot Ali Michael Rosenblum Daniel J Erchick Towfida Jahan Siddiqua Rezwanul Haque Parul Christian Sarah Baker Eleonor Zavala Kerry J Schulze SM Tafsir Hasan Khalid Bin Ahsan Sulagna Bandyopadhyay Hasan Mahmud Sujan Md. Hafizur Rahman Katherine K Stephenson Ximing Ge Ethan K Gough Brooke Langevin Lee Shu Fune Wu Brian Dyer Anjan Kumar Roy Mohammad Jubair Amena Al Nishan Mathangi Gopalakrishnan Klaus Kraemer |
| author_facet | Tahmeed Ahmed Hasmot Ali Michael Rosenblum Daniel J Erchick Towfida Jahan Siddiqua Rezwanul Haque Parul Christian Sarah Baker Eleonor Zavala Kerry J Schulze SM Tafsir Hasan Khalid Bin Ahsan Sulagna Bandyopadhyay Hasan Mahmud Sujan Md. Hafizur Rahman Katherine K Stephenson Ximing Ge Ethan K Gough Brooke Langevin Lee Shu Fune Wu Brian Dyer Anjan Kumar Roy Mohammad Jubair Amena Al Nishan Mathangi Gopalakrishnan Klaus Kraemer |
| author_sort | Tahmeed Ahmed |
| collection | DOAJ |
| description | Introduction Optimising the micronutrient status of women before and during reproduction confers benefits to them and their offspring. Antenatal multiple micronutrient supplements (MMS), given as a daily tablet with nutrients at ~1 recommended dietary allowance (RDA) or adequate intake (AI) reduces adverse birth outcomes. However, at this dosage, MMS may not fully address micronutrient deficiencies in settings with chronically inadequate diets and infection. A bioefficacy study to determine amounts required to attain nutrient adequacy among women of reproductive age (WRA) and pregnant women (PW) aims to address this gap.Methods and analysis Two, four-arm, dose-response trials (n=240 participants/trial) with a double-blind, individually randomised, controlled design are underway in 18–35 year-old WRA and PW in rural northern Bangladesh. The trials will test dose response to four levels of 19 micronutrients from 1 RDA/AI up to ~75% of the tolerable upper intake level (UL), where applicable. These levels of micronutrients are delivered in the form of a reconstituted (in water) powdered drink, daily, including a placebo drink in the control arm, plus a fortified, balanced energy and protein (BEP) food product containing each micronutrient at ~1 RDA per serving. The supplement duration is 3 months in WRA and~6 months (until birth) in PW, who are enrolled at 12–16 weeks of pregnancy; women are randomised to one of the four arms at enrolment. Supplement consumption is directly observed by study staff and weekly side effects and adverse events are monitored. Blood and urine are collected at baseline, a midpoint, and at/near the end of supplementation, with a birth visit and postpartum biospecimen collection (post supplementation) for PW. Outcomes are biomarkers of nutrient status. Pharmacokinetic modelling will estimate micronutrient intakes at which sufficiency for each nutrient without excess is achieved. Enrolment was initiated on 22 October 2023.Ethics and dissemination The study was approved by the Institutional Review Board of Johns Hopkins Bloomberg School of Public Health and the research and ethical review committees of icddr,b, Bangladesh. A data safety and monitoring board is in place for the study. Findings will be disseminated in peer-reviewed papers and in-country meetings.Trial registration number NCT06081114Cite Now |
| format | Article |
| id | doaj-art-d1240d4ff8c54d2a909bce17c1537a6f |
| institution | Kabale University |
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| language | English |
| publishDate | 2025-01-01 |
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| series | BMJ Open |
| spelling | doaj-art-d1240d4ff8c54d2a909bce17c1537a6f2025-01-07T20:15:09ZengBMJ Publishing GroupBMJ Open2044-60552025-01-0115110.1136/bmjopen-2024-090108Micronutrient dose response (MiNDR) study among women of reproductive age and pregnant women in rural Bangladesh: study protocol for double-blind, randomised, controlled trialsTahmeed Ahmed0Hasmot Ali1Michael Rosenblum2Daniel J Erchick3Towfida Jahan Siddiqua4Rezwanul Haque5Parul Christian6Sarah Baker7Eleonor Zavala8Kerry J Schulze9SM Tafsir Hasan10Khalid Bin Ahsan11Sulagna Bandyopadhyay12Hasan Mahmud Sujan13Md. Hafizur Rahman14Katherine K Stephenson15Ximing Ge16Ethan K Gough17Brooke Langevin18Lee Shu Fune Wu19Brian Dyer20Anjan Kumar Roy21Mohammad Jubair22Amena Al Nishan23Mathangi Gopalakrishnan24Klaus Kraemer25Office of Executive Director, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, BangladeshJiVitA Project, Rangpur, BangladeshDepartment of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USACenter for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USAJiVitA Project, Rangpur, BangladeshJiVitA Project, Rangpur, BangladeshCenter for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USACenter for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USACenter for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USACenter for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USANutrition Research Division, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, BangladeshJiVitA Project, Rangpur, BangladeshCenter for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USAJiVitA Project, Rangpur, BangladeshJiVitA Project, Rangpur, BangladeshCenter for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USACenter for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USACenter for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USACenter for Translational Medicine, University of Maryland School of Pharmacy, Baltimore, Maryland, USACenter for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USACenter for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USANutrition Research Division, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, BangladeshInfectious Disease Division, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, BangladeshNutrition Research Division, International Centre for Diarrhoeal Disease Research Bangladesh, Dhaka, BangladeshCenter for Translational Medicine, University of Maryland School of Pharmacy, Baltimore, Maryland, USACenter for Human Nutrition, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USAIntroduction Optimising the micronutrient status of women before and during reproduction confers benefits to them and their offspring. Antenatal multiple micronutrient supplements (MMS), given as a daily tablet with nutrients at ~1 recommended dietary allowance (RDA) or adequate intake (AI) reduces adverse birth outcomes. However, at this dosage, MMS may not fully address micronutrient deficiencies in settings with chronically inadequate diets and infection. A bioefficacy study to determine amounts required to attain nutrient adequacy among women of reproductive age (WRA) and pregnant women (PW) aims to address this gap.Methods and analysis Two, four-arm, dose-response trials (n=240 participants/trial) with a double-blind, individually randomised, controlled design are underway in 18–35 year-old WRA and PW in rural northern Bangladesh. The trials will test dose response to four levels of 19 micronutrients from 1 RDA/AI up to ~75% of the tolerable upper intake level (UL), where applicable. These levels of micronutrients are delivered in the form of a reconstituted (in water) powdered drink, daily, including a placebo drink in the control arm, plus a fortified, balanced energy and protein (BEP) food product containing each micronutrient at ~1 RDA per serving. The supplement duration is 3 months in WRA and~6 months (until birth) in PW, who are enrolled at 12–16 weeks of pregnancy; women are randomised to one of the four arms at enrolment. Supplement consumption is directly observed by study staff and weekly side effects and adverse events are monitored. Blood and urine are collected at baseline, a midpoint, and at/near the end of supplementation, with a birth visit and postpartum biospecimen collection (post supplementation) for PW. Outcomes are biomarkers of nutrient status. Pharmacokinetic modelling will estimate micronutrient intakes at which sufficiency for each nutrient without excess is achieved. Enrolment was initiated on 22 October 2023.Ethics and dissemination The study was approved by the Institutional Review Board of Johns Hopkins Bloomberg School of Public Health and the research and ethical review committees of icddr,b, Bangladesh. A data safety and monitoring board is in place for the study. Findings will be disseminated in peer-reviewed papers and in-country meetings.Trial registration number NCT06081114Cite Nowhttps://bmjopen.bmj.com/content/15/1/e090108.full |
| spellingShingle | Tahmeed Ahmed Hasmot Ali Michael Rosenblum Daniel J Erchick Towfida Jahan Siddiqua Rezwanul Haque Parul Christian Sarah Baker Eleonor Zavala Kerry J Schulze SM Tafsir Hasan Khalid Bin Ahsan Sulagna Bandyopadhyay Hasan Mahmud Sujan Md. Hafizur Rahman Katherine K Stephenson Ximing Ge Ethan K Gough Brooke Langevin Lee Shu Fune Wu Brian Dyer Anjan Kumar Roy Mohammad Jubair Amena Al Nishan Mathangi Gopalakrishnan Klaus Kraemer Micronutrient dose response (MiNDR) study among women of reproductive age and pregnant women in rural Bangladesh: study protocol for double-blind, randomised, controlled trials BMJ Open |
| title | Micronutrient dose response (MiNDR) study among women of reproductive age and pregnant women in rural Bangladesh: study protocol for double-blind, randomised, controlled trials |
| title_full | Micronutrient dose response (MiNDR) study among women of reproductive age and pregnant women in rural Bangladesh: study protocol for double-blind, randomised, controlled trials |
| title_fullStr | Micronutrient dose response (MiNDR) study among women of reproductive age and pregnant women in rural Bangladesh: study protocol for double-blind, randomised, controlled trials |
| title_full_unstemmed | Micronutrient dose response (MiNDR) study among women of reproductive age and pregnant women in rural Bangladesh: study protocol for double-blind, randomised, controlled trials |
| title_short | Micronutrient dose response (MiNDR) study among women of reproductive age and pregnant women in rural Bangladesh: study protocol for double-blind, randomised, controlled trials |
| title_sort | micronutrient dose response mindr study among women of reproductive age and pregnant women in rural bangladesh study protocol for double blind randomised controlled trials |
| url | https://bmjopen.bmj.com/content/15/1/e090108.full |
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