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NCT01678079 · ClinicalTrials.gov registry record · Phase 1
Encapsulated Calcium Absorption in Pregnancy
A Phase 1 study, sponsored by The Hospital for Sick Children.
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
NCT01678079 is a Phase 1 study that has completed, run by The Hospital for Sick Children. The registered enrollment target is 61 participants.
The verdict
NCT01678079, a Phase 1 study, has completed, sponsored by The Hospital for Sick Children.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
Study 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.
Interventions
- DIETARY_SUPPLEMENT Encapsulated Calcium
- DIETARY_SUPPLEMENT Non-capsulated Calcium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2013-02 |
| Est. Completion | 2013-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01678079
The ClinicalTrials.gov registry entry for NCT01678079 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Hospital for Sick Children, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Encapsulated Calcium is the first listed.
NCT01678079 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01678079 about?
NCT01678079 is a clinical study titled "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 ...
What is the current status of trial NCT01678079?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2013-02. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01678079?
The interventions under investigation include: Encapsulated Calcium (DIETARY_SUPPLEMENT), Non-capsulated Calcium (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01678079?
This trial is sponsored by The Hospital for Sick Children, which has 23 total clinical trials registered on ClinicalTrials.gov.
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