NCT01678079

Encapsulated Calcium Absorption in Pregnancy

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: Female
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pregnancy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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).
DIETARY_SUPPLEMENT	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.

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-09-03
• Last updated: 2014-11-18

Locations

4 sites across 3 countries: United States, Bangladesh, Canada