Non-inferiority of low-dose compared to standard high-dose calcium supplementation in pregnancy: study protocol for two randomized, parallel group, non-inferiority trials in India and Tanzania

Abstract Background Hypertensive disorders of pregnancy are important causes of maternal morbidity and mortality, as well as preterm birth, the leading cause of death for children under 5 years globally. The World Health Organization currently recommends that pregnant women receive high-dose calcium...

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Autores principales:	Pratibha Dwarkanath, Alfa Muhihi, Christopher R. Sudfeld, Shobha Rani, Christopher P. Duggan, Mary M. Sando, Blair J. Wylie, Ryan Fernandez, Shabani Kinyogoli, Cristina Munk, Nandita Perumal, John Michael Raj, Nirmala Buggi, Ndeniria Swai, Tinku Thomas, Molin Wang, Anura V. Kurpad, Honorati Masanja, Andreas B. Pembe, Wafaie W. Fawzi
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Calcium Dietary supplements Pregnancy Pregnancy complications Pre-eclampsia Pregnancy-induced hypertension Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/486fe195c0ad46fba27b741ac742c330
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spelling	oai:doaj.org-article:486fe195c0ad46fba27b741ac742c3302021-11-28T12:28:25ZNon-inferiority of low-dose compared to standard high-dose calcium supplementation in pregnancy: study protocol for two randomized, parallel group, non-inferiority trials in India and Tanzania10.1186/s13063-021-05811-71745-6215https://doaj.org/article/486fe195c0ad46fba27b741ac742c3302021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05811-7https://doaj.org/toc/1745-6215Abstract Background Hypertensive disorders of pregnancy are important causes of maternal morbidity and mortality, as well as preterm birth, the leading cause of death for children under 5 years globally. The World Health Organization currently recommends that pregnant women receive high-dose calcium supplementation (1500–2000 mg elemental calcium) for prevention of preeclampsia in populations with low dietary calcium intake. Trials of low-dose calcium supplementation (< 1000 mg elemental calcium/day) during pregnancy have also shown similar reductions in the risk of preeclampsia; however, no trials to date have directly compared low-dose to the standard high-dose calcium supplementation. Our objective is to assess the non-inferiority of low-dose as compared to standard high-dose calcium supplementation in pregnancy. Methods/design We will conduct two independent trials in Bangalore, India (n = 11,000 pregnancies), and Dar es Salaam, Tanzania (n = 11,000 pregnancies). The trial designs are individually randomized, parallel group, quadruple-blind, non-inferiority trials of low-dose calcium supplementation (500 mg elemental calcium/day) as compared to standard high-dose calcium supplementation (1500 mg elemental calcium/day) among nulliparous pregnant women. Pregnant women will be enrolled in the trial before 20 weeks of gestation and will receive the randomized calcium regimen from randomization until the time of delivery. The co-primary outcomes are (i) preeclampsia and (ii) preterm birth; we will test non-inferiority of the primary outcomes for low-dose as compared to the standard high-dose supplementation regimen in each trial. The trials’ secondary outcomes include gestational hypertension, severe features of preeclampsia, pregnancy-related death, third trimester severe anemia, fetal death, stillbirth, low birthweight, small-for-gestational age birth, and infant death. Discussion The trials will provide causal evidence on the non-inferiority of low-dose as compared to the standard high-dose supplementation in India and Tanzania. A single tablet, low-dose calcium supplementation regimen may improve individual-level adherence, reduce programmatic costs, and ultimately expand implementation of routine calcium supplementation in pregnancy in populations with low dietary calcium intake. Trial registration ClinicalTrials.gov identifier: NCT03350516 ; registered on 22 November 2018. Clinical Trials Registry—India identifier: CTRI/2018/02/012119 ; registered on 23 February 2018. Tanzania Medicines and Medical Devices Authority Trials Registry identifier: TFDA0018/CTR/0010/5 ; registered on 20 December 2018.Pratibha DwarkanathAlfa MuhihiChristopher R. SudfeldShobha RaniChristopher P. DugganMary M. SandoBlair J. WylieRyan FernandezShabani KinyogoliCristina MunkNandita PerumalJohn Michael RajNirmala BuggiNdeniria SwaiTinku ThomasMolin WangAnura V. KurpadHonorati MasanjaAndreas B. PembeWafaie W. FawziBMCarticleCalciumDietary supplementsPregnancyPregnancy complicationsPre-eclampsiaPregnancy-induced hypertensionMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Calcium Dietary supplements Pregnancy Pregnancy complications Pre-eclampsia Pregnancy-induced hypertension Medicine (General) R5-920
spellingShingle	Calcium Dietary supplements Pregnancy Pregnancy complications Pre-eclampsia Pregnancy-induced hypertension Medicine (General) R5-920 Pratibha Dwarkanath Alfa Muhihi Christopher R. Sudfeld Shobha Rani Christopher P. Duggan Mary M. Sando Blair J. Wylie Ryan Fernandez Shabani Kinyogoli Cristina Munk Nandita Perumal John Michael Raj Nirmala Buggi Ndeniria Swai Tinku Thomas Molin Wang Anura V. Kurpad Honorati Masanja Andreas B. Pembe Wafaie W. Fawzi Non-inferiority of low-dose compared to standard high-dose calcium supplementation in pregnancy: study protocol for two randomized, parallel group, non-inferiority trials in India and Tanzania
description	Abstract Background Hypertensive disorders of pregnancy are important causes of maternal morbidity and mortality, as well as preterm birth, the leading cause of death for children under 5 years globally. The World Health Organization currently recommends that pregnant women receive high-dose calcium supplementation (1500–2000 mg elemental calcium) for prevention of preeclampsia in populations with low dietary calcium intake. Trials of low-dose calcium supplementation (< 1000 mg elemental calcium/day) during pregnancy have also shown similar reductions in the risk of preeclampsia; however, no trials to date have directly compared low-dose to the standard high-dose calcium supplementation. Our objective is to assess the non-inferiority of low-dose as compared to standard high-dose calcium supplementation in pregnancy. Methods/design We will conduct two independent trials in Bangalore, India (n = 11,000 pregnancies), and Dar es Salaam, Tanzania (n = 11,000 pregnancies). The trial designs are individually randomized, parallel group, quadruple-blind, non-inferiority trials of low-dose calcium supplementation (500 mg elemental calcium/day) as compared to standard high-dose calcium supplementation (1500 mg elemental calcium/day) among nulliparous pregnant women. Pregnant women will be enrolled in the trial before 20 weeks of gestation and will receive the randomized calcium regimen from randomization until the time of delivery. The co-primary outcomes are (i) preeclampsia and (ii) preterm birth; we will test non-inferiority of the primary outcomes for low-dose as compared to the standard high-dose supplementation regimen in each trial. The trials’ secondary outcomes include gestational hypertension, severe features of preeclampsia, pregnancy-related death, third trimester severe anemia, fetal death, stillbirth, low birthweight, small-for-gestational age birth, and infant death. Discussion The trials will provide causal evidence on the non-inferiority of low-dose as compared to the standard high-dose supplementation in India and Tanzania. A single tablet, low-dose calcium supplementation regimen may improve individual-level adherence, reduce programmatic costs, and ultimately expand implementation of routine calcium supplementation in pregnancy in populations with low dietary calcium intake. Trial registration ClinicalTrials.gov identifier: NCT03350516 ; registered on 22 November 2018. Clinical Trials Registry—India identifier: CTRI/2018/02/012119 ; registered on 23 February 2018. Tanzania Medicines and Medical Devices Authority Trials Registry identifier: TFDA0018/CTR/0010/5 ; registered on 20 December 2018.
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author	Pratibha Dwarkanath Alfa Muhihi Christopher R. Sudfeld Shobha Rani Christopher P. Duggan Mary M. Sando Blair J. Wylie Ryan Fernandez Shabani Kinyogoli Cristina Munk Nandita Perumal John Michael Raj Nirmala Buggi Ndeniria Swai Tinku Thomas Molin Wang Anura V. Kurpad Honorati Masanja Andreas B. Pembe Wafaie W. Fawzi
author_facet	Pratibha Dwarkanath Alfa Muhihi Christopher R. Sudfeld Shobha Rani Christopher P. Duggan Mary M. Sando Blair J. Wylie Ryan Fernandez Shabani Kinyogoli Cristina Munk Nandita Perumal John Michael Raj Nirmala Buggi Ndeniria Swai Tinku Thomas Molin Wang Anura V. Kurpad Honorati Masanja Andreas B. Pembe Wafaie W. Fawzi
author_sort	Pratibha Dwarkanath
title	Non-inferiority of low-dose compared to standard high-dose calcium supplementation in pregnancy: study protocol for two randomized, parallel group, non-inferiority trials in India and Tanzania
title_short	Non-inferiority of low-dose compared to standard high-dose calcium supplementation in pregnancy: study protocol for two randomized, parallel group, non-inferiority trials in India and Tanzania
title_full	Non-inferiority of low-dose compared to standard high-dose calcium supplementation in pregnancy: study protocol for two randomized, parallel group, non-inferiority trials in India and Tanzania
title_fullStr	Non-inferiority of low-dose compared to standard high-dose calcium supplementation in pregnancy: study protocol for two randomized, parallel group, non-inferiority trials in India and Tanzania
title_full_unstemmed	Non-inferiority of low-dose compared to standard high-dose calcium supplementation in pregnancy: study protocol for two randomized, parallel group, non-inferiority trials in India and Tanzania
title_sort	non-inferiority of low-dose compared to standard high-dose calcium supplementation in pregnancy: study protocol for two randomized, parallel group, non-inferiority trials in india and tanzania
publisher	BMC
publishDate	2021
url	https://doaj.org/article/486fe195c0ad46fba27b741ac742c330
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Non-inferiority of low-dose compared to standard high-dose calcium supplementation in pregnancy: study protocol for two randomized, parallel group, non-inferiority trials in India and Tanzania

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