Calcium supplementation on pregnant women
This is a trial-based study funded by the Bill and Melinda Gates Foundation. It intends to generate evidence for decision-making on the potential non-inferiority of a lower dose of calcium in preventing preeclampsia and preterm birth. The study also seeks to understand the accessibility, uptake and adherence to the WHO recommended 1500mg calcium supplementation among pregnant women in Tanzania.
During trials planned to last 42 months, researchers will administer a lower dose of calcium supplements – only 500mg instead of 1500mg recommended by the WHO – hoping that it would do the job done by the full dose. The overall aim of the initiative is cutting down the cost from approximately TZS 1500 to only TZS 500 per day and reducing the burden of taking more pills.
The study is being undertaken parallel in India and Tanzania by Ifakara Health Institute, Muhimbili University of Health and Allied Sciences (Muhas), Harvard University, Africa Academy for Public Health and St. John’s Research Institute.
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). There is high-quality evidence from individually randomized controlled trials 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.
The objective of this study is to generate causal evidence for decision-making on the potential non-inferiority of a lower dose of calcium 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 and India.
- Determine if a daily 500mg calcium supplement regimen provides an unacceptably inferior effect on the incidence of preeclampsia than a daily 1500mg calcium supplement regimen among pregnant women in Tanzania.
- Determine if a daily 500mg calcium supplement regimen provides an unacceptably inferior effect on preterm birth than a daily 1500mg calcium supplement regimen among pregnant women in Tanzania.
- Assess the facilitators, enablers, and barriers to implementation of a 1500mg calcium supplement regimen from the perspective of pregnant women and healthcare providers in Tanzanian settings.
We will conduct two, parallel individually randomized, double blind trials in Bangalore, India and Dar es Salaam, Tanzania. Each woman will be randomized to either standard dose (1500 mg) or low dose (500 mg) calcium supplementation. The primary outcomes of the study are: i) preeclampsia, ii) preterm birth.
A parallel, mixed-methods implementation cohort study will also be conducted at one additional health facility in each country to assess the barriers and enablers of health system implementation and individual acceptability and compliance of the WHO-recommended 1500 mg calcium supplementation regimen.
Ifakara Health Institute’s Dr. Honorati Masanja, Principal Investigator, will devote 10% effort to the study. Dr. Masanja is the Chief Executive Director of the Ifakara Health Institute. He will manage the subcontract in Tanzania, provide technical and scientific input for all aspects of the trial and will be in charge of the fiscal management of the subcontract.
He will also provide continuing training and supervision to the study team including physicians and nurses. Similar arrangements in previous trials were successful in achieving efficient progress in the field and prompt resolution of any problems encountered.
Harvard University’s Prof Wafaie Fawz, Principal Investigator, will oversee the scientific, administrative aspects of the study including the maintenance of data collection and management systems, follow-up procedures, and the conduct of statistical analysis.
He will also oversee the budget administration of the project. He spends about 2 months of every year in Tanzania, where he will meet regularly with the colleagues at IHI and AAPH to jointly discuss and monitor the progress of the work.
IHI’s Dr. Francisca Machera is the coordinator of the study in Tanzania. #