Encapsulated Calcium Absorption in Pregnancy

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

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.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• Johns Hopkins Bloomberg School of Public Health

  collaborator OTHER

• Saving Lives at Birth

  collaborator UNKNOWN

• Grand Challenges Canada

  collaborator OTHER

• United States Agency for International Development (USAID)

  collaborator FED

• Government of Norway

  collaborator UNKNOWN

• Bill and Melinda Gates Foundation

  collaborator OTHER

• World Bank

  collaborator OTHER

• The Hospital for Sick Children

  lead OTHER

Principal Investigators

• Daniel Roth, MD · The Hospital for Sick Children

• Stanley Zlotkin, MD · The Hospital for Sick Children

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

30 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-02-28

Primary Completion

2013-06-30

Completion

2013-06-30

Countries

• United States
• Bangladesh
• Canada

Study Locations