NCT01678079: ENCAP

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

Completed Phase 1 Last updated 17 November 2014

What this trial tests

Phase 1 trial testing Encapsulated Calcium in Pregnancy in 61 participants. Completed in 1 June 2013.

Timeline

1 February 2013

Primary endpoint
1 June 2013

1 June 2013

Quick facts

Lead sponsor	The Hospital for Sick Children
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	61
Start date	1 February 2013
Primary completion	1 June 2013
Estimated completion	1 June 2013
Sites	4 locations across United States, Bangladesh, Canada

Drugs / interventions tested

• Encapsulated Calcium
• Non-capsulated Calcium

Conditions studied

• Pregnancy — all drugs for Pregnancy →

Sponsor

The Hospital for Sick Children

Who can join

Adults 18 to 30, female only, with Pregnancy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Fractional Calcium Absorption
  Time frame: 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).
• Fractional Calcium Absorption
  Time frame: Fractional calcium absorption during day 35-36
  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).

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Bioavailability of enteric-coated microencapsulated calcium during pregnancy: a randomized crossover trial in Bangladesh.
   Roth DE, Pezzack B, Al Mahmud A, Abrams SA, et al · · 2014 · cited 10× · PMID 25411294 · DOI 10.3945/ajcn.114.090621