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| Name | Class |
|---|---|
| International Centre for Diarrhoeal Disease Research, Bangladesh | OTHER |
| Baylor College of Medicine | OTHER |
| Johns Hopkins Bloomberg School of Public Health | OTHER |
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This study will enroll at least 60 pregnant women in a randomized cross-over study in Dhaka, Bangladesh. Each participant will be randomized to one of 3 calcium doses: 500 mg, 1000 mg, 1500 mg elemental Ca per day. Each participant will undergo two calcium absorption tests, one with a micronutrient supplement powder containing non-encapsulated (non-coated) calcium and the other with a micronutrient supplement powder containing encapsulated calcium at the same dose. The absorption tests will be separated by a 2-week washout period. Fractional calcium absorption will be measured using the dual stable isotope method. For each test, the formulation will be administered orally for 9 days; on the 10th day, a 44Ca- labeled stable isotope will be given orally and a 42Ca-labeled stable isotope dose will be given intravenously. Urine will be collected for 48 hours to measure calcium absorption.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micronutrient Powder, Enteric-coated Calcium (500 mg/day) | Experimental | Encapsulated Calcium |
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| Micronutrient Powder, Enteric-coated Calcium (1000 mg/day) | Experimental | Encapsulated Calcium |
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| Micronutrient Powder, Enteric-coated Calcium (1500 mg/day) | Experimental | Encapsulated Calcium |
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| Micronutrient Powder, Uncoated Calcium (500 mg/day) | Active Comparator | Non-capsulated Calcium |
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| Micronutrient Powder, Uncoated Calcium (1000 mg/day) | Active Comparator | Non-capsulated Calcium |
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| Micronutrient Powder, Uncoated Calcium (1500 mg/day) | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Encapsulated Calcium | Dietary Supplement | The intervention is a multi-micronutrient powder containing enteric-coated calcium carbonate, in addition to ferrous fumarate (60 mg of elemental iron) and folic acid (400 µg). |
| Measure | Description | Time Frame |
|---|---|---|
| Fractional Calcium Absorption | The primary analysis will be a comparison of mean fractional absorption of the two calcium formulations (enteric-coated vs. non-coated). The secondary analysis will be a comparison of mean fractional absorption across different calcium doses (500, 1000, 1500 mg per day). | Fractional calcium absorption during day 10-11 |
| Fractional Calcium Absorption | The primary analysis will be a comparison of mean fractional absorption of the two calcium formulations (enteric-coated vs. non-coated). The secondary analysis will be a comparison of mean fractional absorption across different calcium doses (500, 1000, 1500 mg per day). | Fractional calcium absorption during day 35-36 |
| Measure | Description | Time Frame |
|---|---|---|
| Palatability and Acceptability | The palatability and acceptability of the microencapsulated and non-encapsulated calcium formulations will be surveyed to assess the following parameters using semi-quantitative measures (i.e. Organoleptic properties, such as taste, odour, texture and colour, and adherence to prescribed micronutrient regimen, and reasons for non-adherence) | Baseline, +10/11 days, +35/36 days |
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Inclusion Criteria:
Exclusion Criteria:
Complicated medical or obstetric history, based on self-report or clinical assessment by physician (e.g., cardiovascular disease, uterine hemorrhage, placenta previa, threatened abortion, hypertension, preeclampsia, multiple gestation, diabetes, renal disease)
Higher risk pregnancy based on one or more of the following clinical findings at time of recruitment:
Reported use of dietary supplements that contain >500 mg of calcium per day and/or >400 IU (10 mcg) of vitamin D per day
Reported use (chewing) of betel leaf, areca nut and lime (together referred to locally as paan) during pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Roth, MD | The Hospital for Sick Children | Principal Investigator |
| Stanley Zlotkin, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Johns Hopkins Bloomberg School of Public Health | Baltimore | Maryland | 21213 | United States | ||
| Baylor College of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25411294 | Derived | Roth DE, Pezzack B, Al Mahmud A, Abrams SA, Islam M, Aimone Phillips A, Baxter JA, Dimitris MC, Hawthorne KM, Ahmed T, Zlotkin SH. Bioavailability of enteric-coated microencapsulated calcium during pregnancy: a randomized crossover trial in Bangladesh. Am J Clin Nutr. 2014 Dec;100(6):1587-95. doi: 10.3945/ajcn.114.090621. Epub 2014 Oct 1. |
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| Saving Lives at Birth |
| UNKNOWN |
| Grand Challenges Canada | OTHER |
| United States Agency for International Development (USAID) | FED |
| Government of Norway | UNKNOWN |
| Bill and Melinda Gates Foundation | OTHER |
| World Bank | OTHER |
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Non-capsulated Calcium
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| Non-capsulated Calcium | Dietary Supplement | The comparator/control intervention is a micronutrient powder containing non-coated calcium (500, 1000 or 1500 mg elemental calcium from calcium carbonate), ferrous fumarate (60 mg of elemental iron) and folic acid (400 µg). This product will be similar in Ca dose, appearance, taste and texture to the experimental formulation but will not include the enteric-coating. |
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| Houston |
| Texas |
| United States |
| International Center for Diarrheal Disease Research | Dhaka | Bangladesh |
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |