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NCT00000429 · ClinicalTrials.gov registry record · Phase 2
Calcium Supplements for Bone Health in Juvenile Rheumatoid Arthritis
A Phase 2 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 2
- Development phase
- 192
- Enrollment target
NCT00000429 is a Phase 2 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 192 participants.
The verdict
NCT00000429, a Phase 2 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 192 participants
- Enrollment target
Study Summary
This study looks at the effects of taking calcium pills on bone health in young people with juvenile rheumatoid arthritis (JRA). In this 2-year study, children aged 6-18 who have JRA will take either a calcium supplement or a matching placebo (inactive or "dummy" pill) containing no calcium. During the study, researchers and patients will not know if a patient is taking calcium or placebo. We believe that patients who take calcium supplements will have at least a 10 percent greater increase in total body bone mineral density compared to patients who take the placebo. We will evaluate patients at Children's Hospital Medical Center every 6 months for 2 years. During this 2-year period, participants in the study will take one multivitamin containing 400 IU (international units) of vitamin D and either 1,000 mg of calcium carbonate (Tums tablets) by mouth or a matching placebo once a day. We will check patients 6 and 18 months after the 2-year treatment period to find out if people in the Tums-treated group maintain any increases in bone formation that occurred during the 2-year treatment period.
Interventions
- DRUG Calcium carbonate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 1996-06 |
| Est. Completion | 2001-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000429
The ClinicalTrials.gov registry entry for NCT00000429 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 192 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Calcium carbonate is the first listed.
NCT00000429 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000429 about?
NCT00000429 is a clinical study titled "Calcium Supplements for Bone Health in Juvenile Rheumatoid Arthritis". This study looks at the effects of taking calcium pills on bone health in young people with juvenile rheumatoid arthritis (JRA). In this 2-year study, children aged 6-18 who have JRA will take either a calcium supplement or a matching placebo (inactive or "dummy" pill) containing no calcium. During ...
What is the current status of trial NCT00000429?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 192 participants. The study started on 1996-06. Estimated completion is 2001-05.
What interventions are being tested in trial NCT00000429?
The interventions under investigation include: Calcium carbonate (DRUG).
Who is sponsoring clinical trial NCT00000429?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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