Clinical trial NCT01678079: Encapsulated Calcium Absorption in Pregnancy
Official title: Bioavailability and Acceptability of Enteric-Coated Microencapsulated Calcium During Pregnancy: A Randomized Crossover Trial in Bangladesh (Encapsulated Calcium Absorption in Pregnancy)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pregnancy
Keywords: Pregnancy
Micronutrient Powder
Calcium
Iron
Bangladesh
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Baylor College of Medicine
name: Johns Hopkins Bloomberg School of Public Health
name: Saving Lives at Birth
name: Grand Challenges Canada
name: United States Agency for International Development (USAID)
name: Government of Norway
name: Bill and Melinda Gates Foundation
name: World Bank
First posted: 2012-09-03
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Fractional Calcium Absorption
timeFrame: Fractional calcium absorption during day 10-11
measure: Fractional Calcium Absorption
timeFrame: Fractional calcium absorption during day 35-36
Secondary outcomes:
measure: Palatability and Acceptability
timeFrame: Baseline, +10/11 days, +35/36 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Johns Hopkins Bloomberg School of Public Health
state: Maryland
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Dhaka
country: Bangladesh
facility: International Center for Diarrheal Disease Research
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Daniel Roth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children
name: Stanley Zlotkin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roth DE, Pezzack B, Al Mahmud A, Abrams SA, Islam M, Aimone Phillips A, Baxter JA, Dimitris MC, Hawthorne KM, Ahmed T, Zlotkin SH. Bioavailability of enteric-coated microencapsulated calcium during pregnancy: a randomized crossover trial in Bangladesh. Am J Clin Nutr. 2014 Dec;100(6):1587-95. doi: 10.3945/ajcn.114.090621. Epub 2014 Oct 1.