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| Name | Class |
|---|---|
| St. John's Research Institute | OTHER |
| Ifakara Health Institute | OTHER |
| Africa Academy for Public Health | OTHER |
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The World Health Organization currently recommends that pregnant women in populations with low calcium intake receive daily calcium supplementation (1500 - 2000 mg) divided into three doses which are preferably taken at mealtimes, in addition to daily iron folic-acid supplements. Despite proven efficacy and the WHO recommendation, calcium supplementation in pregnancy is not standard of care in the vast majority of low-income and middle-income countries. Two important barriers to implementation are the cost of the supplements and complexity of the suggested calcium dosing schedule. A lower dose of calcium (500 mg) administered as a single dose has been shown to be beneficial in several trials, and if found to be as effective as the 1500 mg supplementation regimen, it may help overcome these barriers and increase individual and health system adoption.
The Investigators will conduct two parallel, individually randomized, double blind non-inferiority trials in India and Tanzania. Participating pregnant woman will be randomized to either 1500 mg or 500 mg calcium supplementation. The India and Tanzania trials are independently powered for the primary outcomes of i) preeclampsia and ii) preterm birth. The India and Tanzania sites will each enroll 11,000 participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily 500 mg Calcium | Experimental |
| |
| Daily1500 mg Calcium (Standard dose) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daily 500 mg elemental calcium as calcium carbonate | Dietary Supplement | Pregnant women in this arm will be provided and counselled to take three tablets, one containing 500 mg elemental calcium as calcium carbonate and 2 placebo supplements daily (total of 500 mg daily). The supplements in India will also contain 83.3 IU each of vitamin D3, for a total of 250 IU daily. No vitamin D3 will be given in Tanzania. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of pregnant women with incident preeclampsia | Gestational week 20 to Delivery | |
| Proportion of preterm birth | Birth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wafaie W Fawzi, MBBS, DrPH | Harvard School of Public Health (HSPH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. John's Research Institute | Bangalore | India | ||||
| Africa Academy for Public Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38197817 | Result | Dwarkanath P, Muhihi A, Sudfeld CR, Wylie BJ, Wang M, Perumal N, Thomas T, Kinyogoli SM, Bakari M, Fernandez R, Raj JM, Swai NO, Buggi N, Shobha R, Sando MM, Duggan CP, Masanja HM, Kurpad AV, Pembe AB, Fawzi WW. Two Randomized Trials of Low-Dose Calcium Supplementation in Pregnancy. N Engl J Med. 2024 Jan 11;390(2):143-153. doi: 10.1056/NEJMoa2307212. | |
| 42067065 |
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| ID | Term |
|---|---|
| D002118 | Calcium |
| D002119 | Calcium Carbonate |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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|
| Daily1500 mg elemental calcium as calcium carbonate | Dietary Supplement | Pregnant women in this arm will be provided and counselled to take three tablets each containing 500 mg elemental calcium as calcium carbonate daily (total of 1500 mg daily) as currently recommended by the World Health Organization. The supplements in India will also contain 83.3 IU each of vitamin D3, for a total of 250 IU daily. No vitamin D3 will be given in Tanzania. |
|
| Dar es Salaam |
| Tanzania |
| Ifakara Health Institute | Dar es Salaam | Tanzania |
| Ali NB, Sudfeld CR, Muhihi A, Thomas T, Perumal N, Sando MM, Masanja HM, Partap U, Duggan CP, Kurpad AV, Dwarkanath P, Pembe AB, Fawzi WW. Effect of calcium supplementation in pregnancy on maternal anemia and iron status: secondary analyses of two randomized trials in India and Tanzania. Am J Clin Nutr. 2026 Jul;124(1):101338. doi: 10.1016/j.ajcnut.2026.101338. Epub 2026 Apr 30. |
| 40639854 | Derived | Pembe AB, Dwarkanath P, Kikula A, Raj JM, Perumal N, Paulo HA, M R, Duggan CP, Masanja HM, Chopra N, Sando MM, Thomas T, Yelverton CA, Muhihi A, Kurpad AV, Fawzi WW, Wylie BJ, Sudfeld CR. Hypertensive disorders of pregnancy and perinatal outcomes: two prospective cohort studies of nulliparous women in India and Tanzania. BMJ Glob Health. 2025 Jul 10;10(7):e016339. doi: 10.1136/bmjgh-2024-016339. |
| 34819147 | Derived | Dwarkanath P, Muhihi A, Sudfeld CR, Rani S, Duggan CP, Sando MM, Wylie BJ, Fernandez R, Kinyogoli S, Munk C, Perumal N, Raj JM, Buggi N, Swai N, Thomas T, Wang M, Kurpad AV, Masanja H, Pembe AB, Fawzi WW. Non-inferiority of low-dose compared to standard high-dose calcium supplementation in pregnancy: study protocol for two randomized, parallel group, non-inferiority trials in India and Tanzania. Trials. 2021 Nov 24;22(1):838. doi: 10.1186/s13063-021-05811-7. |
| D001779 |
| Blood Coagulation Factors |
| D001685 | Biological Factors |
| D017610 | Calcium Compounds |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D008903 | Minerals |