Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
61 participants
INTERVENTIONAL
2013-02-28
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Micronutrient Powder, Enteric-coated Calcium (500 mg/day)
Encapsulated Calcium
Encapsulated Calcium
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).
Micronutrient Powder, Enteric-coated Calcium (1000 mg/day)
Encapsulated Calcium
Encapsulated Calcium
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).
Micronutrient Powder, Enteric-coated Calcium (1500 mg/day)
Encapsulated Calcium
Encapsulated Calcium
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).
Micronutrient Powder, Uncoated Calcium (500 mg/day)
Non-capsulated Calcium
Non-capsulated Calcium
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.
Micronutrient Powder, Uncoated Calcium (1000 mg/day)
Non-capsulated Calcium
Non-capsulated Calcium
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.
Micronutrient Powder, Uncoated Calcium (1500 mg/day)
Non-capsulated Calcium
Non-capsulated Calcium
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.
Interventions
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Encapsulated Calcium
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).
Non-capsulated Calcium
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.
Eligibility Criteria
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Inclusion Criteria
* Current residence in Dhaka at a fixed address
* Plan to remain in Dhaka for at least 2 months from date of enrolment
* Gestational age of 27 completed weeks ± 1 week, estimated based on the recalled first day of the last menstrual period (LMP)
Exclusion Criteria
* Higher risk pregnancy based on one or more of the following clinical findings at time of recruitment:
* Severe anemia (hemoglobin \<70 g/L assessed by Hemocue)
* Proteinuria (≥ 100 mg/dl based on urine dipstick)
* Glycosuria (≥ 100 mg/dl based on urine dipstick)
* Hypertension (systolic blood pressure, ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg)
* 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
18 Years
30 Years
FEMALE
Yes
Sponsors
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International Centre for Diarrhoeal Disease Research, Bangladesh
OTHER
Baylor College of Medicine
OTHER
Johns Hopkins Bloomberg School of Public Health
OTHER
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
The Hospital for Sick Children
OTHER
Responsible Party
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Daniel Roth
Staff Physician, Paediatric Medicine
Principal Investigators
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Daniel Roth, MD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Stanley Zlotkin, MD
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Locations
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The Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States
Baylor College of Medicine
Houston, Texas, United States
International Center for Diarrheal Disease Research
Dhaka, , Bangladesh
The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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References
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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.
Other Identifiers
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1000033463
Identifier Type: -
Identifier Source: org_study_id