Encapsulated Calcium Absorption in Pregnancy

Completed · Phase 1

Conditions studied: Pregnancy

In brief

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.

Key facts

Study ID

NCT01678079

Run by

The Hospital for Sick Children

People needed

61

Starts

2013-02-01

Expected to finish

2013-06-01

Last updated by the study team

2014-11-18

Who can join

Age: 18 and older, up to 30. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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