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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: Completed Phase 1 study, sponsored by The Hospital for Sick Children.
NCT01678079 is a Phase 1 study that has completed, run by The Hospital for Sick Children. The registered enrollment target is 61 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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).
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 |
What the finished NCT01678079 record still lists
NCT01678079 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Encapsulated Calcium is the first listed.
NCT01678079 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01678079's enrollment target sits among peer trials
61 828th of 2000 higher than 1,170 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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