Encapsulated Calcium Absorption in Pregnancy (ENCAP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
International Centre for Diarrhoeal Disease Research, Bangladesh
Baylor College of Medicine
Johns Hopkins Bloomberg School of Public Health
Saving Lives at Birth
Grand Challenges Canada
United States Agency for International Development (USAID)
Government of Norway
Bill and Melinda Gates Foundation
World Bank
Information provided by (Responsible Party):
Daniel Roth, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01678079
First received: August 30, 2012
Last updated: June 7, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Pregnancy
Dietary Supplement: Encapsulated Calcium
Dietary Supplement: Non-capsulated Calcium
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bioavailability and Acceptability of Enteric-Coated Microencapsulated Calcium During Pregnancy: A Randomized Crossover Trial in Bangladesh (Encapsulated Calcium Absorption in Pregnancy)

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Fractional Calcium Absorption [ Time Frame: Fractional calcium absorption during day 10-11 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Palatability and Acceptability [ Time Frame: Baseline, +10/11 days, +35/36 days ] [ Designated as safety issue: No ]
    The palatability and acceptability of the microencapsulated and non-encapsulated calcium formulations will be surveyed to assess the following parameters using semi-quantitative measures (i.e. Organoleptic properties, such as taste, odour, texture and colour, and adherence to prescribed micronutrient regimen, and reasons for non-adherence)


Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Micronutrient Powder, Enteric-coated Calcium (500 mg/day)
Encapsulated Calcium
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).
Experimental: Micronutrient Powder, Enteric-coated Calcium (1000 mg/day)
Encapsulated Calcium
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).
Experimental: Micronutrient Powder, Enteric-coated Calcium (1500 mg/day)
Encapsulated Calcium
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).
Active Comparator: Micronutrient Powder, Uncoated Calcium (500 mg/day)
Non-capsulated Calcium
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.
Active Comparator: Micronutrient Powder, Uncoated Calcium (1000 mg/day)
Non-capsulated Calcium
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.
Active Comparator: Micronutrient Powder, Uncoated Calcium (1500 mg/day)
Non-capsulated Calcium
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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678079

Locations
United States, Maryland
The Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21213
United States, Texas
Baylor College of Medicine
Houston, Texas, United States
Bangladesh
International Center for Diarrheal Disease Research
Dhaka, Bangladesh
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
International Centre for Diarrhoeal Disease Research, Bangladesh
Baylor College of Medicine
Johns Hopkins Bloomberg School of Public Health
Saving Lives at Birth
Grand Challenges Canada
United States Agency for International Development (USAID)
Government of Norway
Bill and Melinda Gates Foundation
World Bank
Investigators
Principal Investigator: Daniel Roth, MD The Hospital for Sick Children
Principal Investigator: Stanley Zlotkin, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Daniel Roth, Staff Physician, Paediatric Medicine, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01678079     History of Changes
Other Study ID Numbers: 1000033463
Study First Received: August 30, 2012
Last Updated: June 7, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:
Pregnancy
Micronutrient Powder
Calcium
Iron
Bangladesh

Additional relevant MeSH terms:
Calcium, Dietary
Micronutrients
Trace Elements
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Growth Substances

ClinicalTrials.gov processed this record on August 27, 2014