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Two Randomized Trials of Low-Dose Calcium Supplementation in Pregnancy

医学 相对风险 随机对照试验 置信区间 怀孕 子痫前期 坦桑尼亚 入射(几何) 产科 活产 内科学 遗传学 环境科学 物理 环境规划 光学 生物
作者
Pratibha Dwarkanath,Alfa Muhihi,Christopher R. Sudfeld,Blair J. Wylie,Molin Wang,Nandita Perumal,Tinku Thomas,Shabani Kinyogoli,Mohamed Bakari,Ryan Fernandez,John-Michael Raj,Ndeniria Swai,Nirmala Buggi,R Shobha,Mary M. Sando,Christopher Duggan,Honorati Masanja,Anura V. Kurpad,Andrea B. Pembe,Wafaie Fawzi
出处
期刊:The New England Journal of Medicine [Massachusetts Medical Society]
卷期号:390 (2): 143-153 被引量:13
标识
DOI:10.1056/nejmoa2307212
摘要

BackgroundThe World Health Organization recommends 1500 to 2000 mg 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.MethodsWe conducted two independent randomized trials of calcium supplementation, in India and Tanzania, to assess the noninferiority of a 500-mg daily dose to a 1500-mg 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.ResultsA 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-mg group in the India trial (relative risk, 0.84; 95% confidence interval [CI], 0.68 to 1.03) and 3.0% and 2.7%, 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 1.16; in the Tanzania trial, the respective percentages were 10.4% and 9.7% (relative risk, 1.07; 95% CI, 0.95 to 1.21), which exceeded the noninferiority margin.ConclusionsIn these two trials, low-dose calcium supplementation was noninferior to high-dose calcium supplementation with respect to the risk of preeclampsia. It was noninferior 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).
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