Pregnancy
Conditions
Keywords
Pregnancy, Micronutrient Powder, Calcium, Iron, Bangladesh
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTEncapsulated 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).
DIETARY_SUPPLEMENTNon-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.
Sponsors
International Centre for Diarrhoeal Disease Research, Bangladesh
Baylor College of Medicine
Johns Hopkins Bloomberg School of Public Health
Saving Lives at Birth
Grand Challenges Canada
United States Agency for International Development (USAID)
Government of Norway
Bill and Melinda Gates Foundation
World Bank
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Women aged 18 to 30 years * 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
* 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: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fractional Calcium Absorption | Fractional calcium absorption during day 10-11 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Palatability and Acceptability | Baseline, +10/11 days, +35/36 days | 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) |
Countries
Bangladesh, Canada, United States
Outcome results
None listed