Encapsulated Calcium Absorption in Pregnancy

Phase 1

Completed

• Conditions: Pregnancy
• Interventions: Dietary Supplement: Encapsulated Calcium; Dietary Supplement: Non-capsulated Calcium

• Registration Number: NCT01678079
• Lead Sponsor: The Hospital for Sick Children

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-30
• Study First Submitted QC: 2012-08-31
• Study First Posted: 2012-09-03
• Study Start: 2013-02
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 61

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Micronutrient Powder, Enteric-coated Calcium (1000 mg/day)	Encapsulated Calcium	Encapsulated Calcium
Micronutrient Powder, Enteric-coated Calcium (500 mg/day)	Encapsulated Calcium	Encapsulated Calcium
Micronutrient Powder, Enteric-coated Calcium (1500 mg/day)	Encapsulated Calcium	Encapsulated Calcium
Micronutrient Powder, Uncoated Calcium (1500 mg/day)	Non-capsulated Calcium	Non-capsulated Calcium
Micronutrient Powder, Uncoated Calcium (500 mg/day)	Non-capsulated Calcium	Non-capsulated Calcium
Micronutrient Powder, Uncoated Calcium (1000 mg/day)	Non-capsulated Calcium	Non-capsulated Calcium

Primary Outcome Measures

Name	Time	Method
Fractional Calcium Absorption	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

Name	Time	Method
Palatability and Acceptability	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)

Trial Locations

Locations (4)

The Johns Hopkins Bloomberg School of Public Health; 🇺🇸 Baltimore, Maryland, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

International Center for Diarrheal Disease Research; 🇧🇩 Dhaka, Bangladesh

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada