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Encapsulated Calcium Absorption in Pregnancy (ENCAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01678079
Recruitment Status : Completed
First Posted : September 3, 2012
Last Update Posted : November 18, 2014
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

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Pregnancy Dietary Supplement: Encapsulated Calcium Dietary Supplement: Non-capsulated Calcium Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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)
Study Start Date : February 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium Pregnancy

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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).


Secondary Outcome Measures :
  1. Palatability and Acceptability [ Time Frame: Baseline, +10/11 days, +35/36 days ]
    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)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678079


Locations
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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
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Principal Investigator: Daniel Roth, MD The Hospital for Sick Children
Principal Investigator: Stanley Zlotkin, MD The Hospital for Sick Children
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Daniel Roth, Staff Physician, Paediatric Medicine, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01678079    
Other Study ID Numbers: 1000033463
First Posted: September 3, 2012    Key Record Dates
Last Update Posted: November 18, 2014
Last Verified: November 2014
Keywords provided by Daniel Roth, The Hospital for Sick Children:
Pregnancy
Micronutrient Powder
Calcium
Iron
Bangladesh
Additional relevant MeSH terms:
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Calcium, Dietary
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents