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NCT Number: NCT01678079

Encapsulated Calcium Absorption in Pregnancy

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.

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Key information

Conditions

Pregnancy

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

International Center for Diarrheal Disease Research, Dhaka, Bangladesh

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Encapsulated Calcium

Dietary Supplement

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

Dietary Supplement

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.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: ENCAP

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 3, 2012
Registry last updated
Nov 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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