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PregnancyPhase 1ENCAPNCT01678079

Encapsulated Calcium Absorption in Pregnancy

A Phase 1 study testing Encapsulated Calcium and Non-capsulated Calcium in people with Pregnancy, run by The Hospital for Sick Children at 4 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 30 years, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy
What is being tested?
Encapsulated Calcium and Non-capsulated Calcium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
4 sitesin 3 countries
Study dates
Feb 2013to Jun 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

4 sites in 3 countries.

4 sites in 3 countries

United States2 sites

  • The Johns Hopkins Bloomberg School of Public Health

    Baltimore, Maryland, 21213

  • Baylor College of Medicine

    Houston, Texas

Other trials in United States

Bangladesh1 site

  • International Center for Diarrheal Disease Research

    Dhaka

Other trials in Bangladesh

Canada1 site

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

About this study

Official title: Bioavailability and Acceptability of Enteric-Coated Microencapsulated Calcium During Pregnancy: A Randomized Crossover Trial in Bangladesh (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.

Conditions
Pregnancy
Being tested
Encapsulated Calcium, Non-capsulated Calcium
Keywords
Pregnancy, Micronutrient Powder, Calcium, Iron, Bangladesh

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Encapsulated CalciumDietary 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 CalciumDietary 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.

Study groups in NCT01678079
Study groupRoleWhat they receive
Micronutrient Powder, Enteric-coated Calcium (500 mg/day)ExperimentalEncapsulated Calcium
Receives: Dietary Supplement: Encapsulated Calcium
Micronutrient Powder, Enteric-coated Calcium (1000 mg/day)ExperimentalEncapsulated Calcium
Receives: Dietary Supplement: Encapsulated Calcium
Micronutrient Powder, Enteric-coated Calcium (1500 mg/day)ExperimentalEncapsulated Calcium
Receives: Dietary Supplement: Encapsulated Calcium
Micronutrient Powder, Uncoated Calcium (500 mg/day)Active comparatorNon-capsulated Calcium
Receives: Dietary Supplement: Non-capsulated Calcium
Micronutrient Powder, Uncoated Calcium (1000 mg/day)Active comparatorNon-capsulated Calcium
Receives: Dietary Supplement: Non-capsulated Calcium
Micronutrient Powder, Uncoated Calcium (1500 mg/day)Active comparatorNon-capsulated Calcium
Receives: Dietary Supplement: Non-capsulated Calcium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Fractional calcium absorption during day 10-11

  2. 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).

    Measured: Fractional calcium absorption during day 35-36

Secondary outcomes (1)

  1. 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)

    Measured: Baseline, +10/11 days, +35/36 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2012 (estimated)
  2. Study startFeb 2013
  3. Primary completionJun 2013
  4. Study completionJun 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01678079
Sponsor's protocol ID
1000033463
Acronym
ENCAP
Status last verified
Nov 2014
First submitted
30 Aug 2012
Last updated
18 Nov 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25411294

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Encapsulated Calcium and Non-capsulated Calcium in people with Pregnancy, run by The Hospital for Sick Children at 4 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Bangladesh, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fractional Calcium Absorption (time frame: Fractional calcium absorption during day 10-11). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01678079, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2014.

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