Encapsulated Calcium Absorption in Pregnancy (ENCAP)
This study is currently recruiting participants.
Verified April 2013 by The Hospital for Sick Children
Sponsor:
The Hospital for Sick Children
Collaborators:
International Centre for Diarrhoeal Disease Research, Bangladesh
Baylor College of Medicine
The Johns Hopkins Bloomberg School of Public Health (JHU)
Saving Lives at Birth partners, as follows
Grand Challenges Canada
United States Agency for International Development (USAID)
The Government of Norway
The Bill & Melinda Gates Foundation
World Bank
Information provided by (Responsible Party):
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01678079
First received: August 30, 2012
Last updated: April 12, 2013
Last verified: April 2013
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678079
Contacts
| Contact: Daniel Roth, MD | (416)813-5795 | daniel.roth@sickkids.ca |
Locations
| United States, Maryland | |
| The Johns Hopkins Bloomberg School of Public Health | Active, not recruiting |
| Baltimore, Maryland, United States, 21213 | |
| United States, Texas | |
| Baylor College of Medicine | Active, not recruiting |
| Houston, Texas, United States | |
| Bangladesh | |
| International Center for Diarrheal Disease Research | Recruiting |
| Dhaka, Bangladesh | |
| Contact: Abdullah Al Mahmud, MD +8802-9840523-32 ext 3807 mahmud@icddrb.org | |
| Sub-Investigator: Abdullah Al Mahmud, MD | |
| Sub-Investigator: Tahmeed Ahmed, MD | |
| Sub-Investigator: Munirul Islam, MD | |
| Sub-Investigator: Steven Abrams, MD | |
| Sub-Investigator: Abdullah Baqui, MD | |
| Canada, Ontario | |
| The Hospital for Sick Children | Active, not recruiting |
| Toronto, Ontario, Canada, M5G 1X8 | |
Sponsors and Collaborators
The Hospital for Sick Children
International Centre for Diarrhoeal Disease Research, Bangladesh
Baylor College of Medicine
The Johns Hopkins Bloomberg School of Public Health (JHU)
Saving Lives at Birth partners, as follows
Grand Challenges Canada
United States Agency for International Development (USAID)
The Government of Norway
The Bill & 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: | 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: | April 12, 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 May 21, 2013