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St John’s Research Institute’s trial on low-dose calcium supplementation proves to stall pre-terms births

Nandita Vijayasimha, Bengaluru
Thursday, May 23, 2024, 08:00 Hrs  [IST]

St John’s Research Institute’s clinical trial on low-dose calcium supplementation has proved to stall pre-terms births. The clinical trial was conducted in Bengaluru and Dar es Salaam, Tanzania. It was found that low-dose calcium supplementation was equally effective as high-dose supplementation in preventing preeclampsia.

Trials were funded by the Bill and Melinda Gates Foundation, in collaboration with the Harvard TH Chan School of Public Health. The study was conducted on 11,000 nulliparous pregnant women by a team of researchers led by Dr Pratibha Dwarkanath and Prof Anura Kurpad from St John’s Research Institute and St John’s Medical College.

In the study, two independent randomised trials of calcium supplementation in India and Tanzania were conducted to assess the noninferiority of a 500-mg daily dose to a 1,500-mg daily dose of calcium supplementation. The pregnant women were recruited at 20 weeks of gestation and were followed up until delivery.

The recommended dose of calcium daily is 1,500–2,000 mg. This is divided into three doses for pregnant people in populations with low dietary intake, to reduce the risk of preeclampsia. The complexity of the dosing scheme however, led to implementation barriers.

The Indian study was part of two independent trials on a similar number of women, and the other trial was conducted in Dar es Salaam, Tanzania. The study titled ‘Two Randomised Trials of Low-Dose Calcium Supplementation in Pregnancy’ was published in The New England Journal of Medicine.

The human studies indicated that hypertensive disorders of pregnancy, which include preeclampsia, complicate 2–8% of pregnancies and are estimated to cause 45,000 maternal deaths annually. These disorders are also associated with an increased risk of preterm birth, the leading cause of death among children worldwide.

Since 2011, World Health Organization (WHO) recommends calcium supplementation during pregnancy, particularly for populations with low dietary calcium intake, to reduce the risk of conditions like preeclampsia.

Preeclampsia is a serious complication characterized by high blood pressure and signs of damage to other organs, often occurring after the 20th week of pregnancy.

Calcium supplementation has been shown to have a protective effect against preeclampsia in various studies. It's typically advised for pregnant women to ensure they meet their daily calcium requirements through diet and supplementation if necessary, under medical supervision.

According to Dr Pratibha Dwarkanath, associate professor, division of nutrition, St John’s Research Institute, “The study found that low-dose calcium supplementation was equally effective as high-dose supplementation in preventing preeclampsia. In the India trial, the incidence of preeclampsia was 3.0% for women taking 500 mg/day and 3.6% for those taking 1,500 mg/day. In Tanzania, the incidence was 3.0% and 2.7%, respectively.”

Regarding preterm birth, results varied between trials. In India, the incidence was 11.4% for low-dose and 12.8% for high-dose, indicating similar effects. In Tanzania, the rates were 10.4% and 9.7%, respectively. However, when pooling data from both trials, the study found no significant difference in the effect of low-dose versus high-dose supplementation on preterm birth, she added.

 




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