1. Two Randomized Trials of Low-Dose Calcium Supplementation in Pregnancy.
- Author
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Dwarkanath, Pratibha, Muhihi, Alfa, Sudfeld, Christopher R., Wylie, Blairl, Molin Wang, Perumal, Nandita, Thomas, Tinku, Kinyogoli, Shabani M., Bakari, Moharned, Fernandez, Ryan, Raj, John-Michael, Swai, Ndeniria O., Buggi, Nirmala, Shobha, Rani, Sando, Mary M., Duggan, Christopher P., Masanja, Honorati M., Kurpad, Anura V., Pembe, Andrea B., and Fawzi, Wafaie W.
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DIETARY calcium , *DIETARY supplements , *CALCIUM , *PREMATURE labor , *FOOD consumption - Abstract
BACKGROUND The World Health Organization recommends 1500 to 2000 Ing of calcium daily as supplementation, divided into three doses, for pregnant persons in populations with low dietary calcium intake in order to reduce the risk of preeclampsia. The complexity of the dosing scheme, however, has led to implementation barriers. METHODS We conducted two independent randomized trials of calcium supplementation, in India and Tanzania, to assess tlie noninferiority of a 500-nig daily dose to a 1500-nig daily dose of calcium supplementation. In each trial, the two primary outcomes were preeclampsia and preterm birth, and the noninferiority margins for the relative risks were 1.54 and 1.16, respectively. RESULTS A total of 11,000 nulliparous pregnant women were included in each trial. The cumulative incidence of preeclampsia was 3.0% in the 500-mg group and 3.6% in the 1500-Ing group in the India trial (relative risk, 0.84; 95°6 confidence interval ICI], 0.68 to 1.03) and 3.0% and 2.7°6, respectively, in the Tanzania trial (relative risk, 1.10; 95% CI, 0.88 to 1.36) - findings consistent with the noninferiority of the lower dose in both trials. The percentage of live births that were preterm was 11.4% in the 500-mg group and 12.8% in the 1500-mg group in the India trial (relative risk, 0. 89; 95 % CI, 0. 80 to 0.98), which was within the noninferiority margin of 1. 54; in the Tanzania trial, the respective percentages were 10.4% and 9.7°/0 (relative risk, 1.07; 95% CI, 0.95 to 1.21), which exceeded the noninferiority margin of 1.16. CONCLUSIONS In these two trials, low-dose calcium supplementation was nonin ferior to high-dose calcium supplementation with respect to the risk of preeclampsia. It was non-inferior with respect to the risk of preterm live birth in the trial in India but not in the trial in Tanzania. (Funded by the Bill and Melinda Gates Foundation and others; ClinicalTrials.gov number, NCT03350516; Clinical Trials Registry-India number, CTRI/2018/02/012119; and Tanzania Medicines and Medical Devices Authority Trials Registry number, TFDA0018/CTR/0010/5). [ABSTRACT FROM AUTHOR]
- Published
- 2024
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