Calcium Supplementation Clinical Trial.

Hypertensive disorders complicate 6-7% of pregnancies; they are a major cause of maternal and perinatal morbidity and mortality in low- and middle-income countries (LMIC). Evidence shows that calcium supplementation during pregnancy decreases the risk of developing pregnancy-related hypertensive disorders by more than one half; it also significantly reduces the risk of preterm birth. The World Health Organization (WHO) currently recommends pregnant women living in areas with low calcium intake consume daily calcium supplementation (1500 – 2000 mg) divided into three doses and preferably taken at mealtimes, in addition to iron folic-acid once daily. Despite its proven efficacy and the WHO recommendation, calcium supplementation in pregnancy is not standard of care in the vast majority of LMIC settings. Two important barriers to implementation are the cost of the supplements and complexity of the suggested dosing schedule. An equally effective lower dose of calcium (500 mg) administered as a single dose, may help overcome these barriers and increase individual and health system adoption of this effective intervention.
AAPH is undertaking data management in this ongoing trial funded by the Bill & Melinda Gates Foundation aimed at generating causal evidence for decision-making on the potential non-inferiority of a lower dose of calcium (500 mg) in preventing preeclampsia and preterm birth and to understand the acceptability, uptake, and adherence to the WHO recommended 1500 mg calcium supplementation among pregnant women in Tanzania. We are conducting, individually randomized, double blind trials in Dar es Salaam, Tanzania. Each woman will be randomized to either standard dose (1500 mg) or low dose (500 mg) calcium supplementation. A parallel, mixed-methods implementation cohort study is also being conducted at one additional health facility in India and Tanzania to assess the barriers and enablers of health system implementation and individual acceptability and compliance of the WHO-recommended 1500 mg calcium supplementation regimen.