Encapsulated Calcium Absorption in Pregnancy

Status:	Completed
Conditions:	Women's Studies
Therapuetic Areas:	Reproductive
Healthy:	No
Age Range:	18 - 30
Updated:	5/27/2013
Start Date:	February 2013
End Date:	June 2013
Contact:	Daniel Roth, MD
Email:	daniel.roth@sickkids.ca
Phone:	(416)813-5795

Bioavailability and Acceptability of Enteric-Coated Microencapsulated Calcium During Pregnancy: A Randomized Crossover Trial in Bangladesh (Encapsulated Calcium Absorption in Pregnancy)

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.

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

We found this trial at

sites

Baylor College of Medicine

1200 Moursund Street
Houston, Texas 77030

(713) 798-4951