Encapsulated Calcium Absorption in Pregnancy

Pregnancy Clinical Trial

— ENCAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01678079
• Other study ID #: 1000033463
• Status: Completed
• Phase: Phase 1
• First received: August 30, 2012
• Last updated: November 17, 2014
• Start date: February 2013
• Est. completion date: June 2013

Study information

• Verified date: November 2014
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy

Intervention

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).
• 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.

Locations

Country	Name	City	State
Bangladesh	International Center for Diarrheal Disease Research	Dhaka
Canada	The Hospital for Sick Children	Toronto	Ontario
United States	The Johns Hopkins Bloomberg School of Public Health	Baltimore	Maryland
United States	Baylor College of Medicine	Houston	Texas

Sponsors (10)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Baylor College of Medicine, Bill and Melinda Gates Foundation, Government of Norway, Grand Challenges Canada, International Centre for Diarrhoeal Disease Research, Bangladesh, Johns Hopkins Bloomberg School of Public Health, Saving Lives at Birth, United States Agency for International Development (USAID), World Bank

Countries where clinical trial is conducted

United States,  Bangladesh,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional Calcium Absorption	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 during day 10-11	No
Primary	Fractional Calcium Absorption	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 during day 35-36	No
Secondary	Palatability and Acceptability	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)	Baseline, +10/11 days, +35/36 days	No