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NCT00724178 · ClinicalTrials.gov registry record · Phase 2
The Effect of Vitamin D and Calcium on Bone in Pediatric HIV
A Phase 2 study of HIV Infection and Bone Mass, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 59
- Enrollment target
- 1
- Study location
NCT00724178 is a Phase 2 study of HIV Infection and Bone Mass that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 59 participants, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (76% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00724178, a Phase 2 study of HIV Infection and Bone Mass, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 59 participants
- Enrollment target
- 1
- Study location
Study Summary
We have observed that vitamin D deficiency, as evidenced by low serum 25(OH)D concentrations, is common in children and adolescents with HIV infection. To determine whether vitamin D and calcium supplementation improve bone mineral content (BMC) and bone mineral density (BMD) in HIV-infected children and adolescents, we propose a double-blind, randomized, placebo-controlled trial comparing supplementation with oral vitamin D and calcium to placebo. The specific aims of this project are to: 1. Determine the effect of vitamin D and calcium supplementation on bone mineral accrual in HIV-infected children. We hypothesize that BMC and BMD will increase to a greater extent in HIV-infected children who receive supplementation with vitamin D and calcium. This hypothesis will be tested by comparing changes in BMC and BMD, measured by dual energy x-ray absorptiometry (DXA), after one and two years of treatment in HIV-infected children and adolescents receiving vitamin D and calcium supplementation compared to those receiving placebo. 2. Determine the effect of HIV infection and vitamin D and calcium supplementation on indices of mineral metabolism and markers of bone turnover. We hypothesize that indices of mineral metabolism and markers of bone formation and resorption will return toward normal in HIV-infected children and adolescents who are randomized to receive vitamin D and calcium supplementation. We will test these hypotheses by comparing longitudinal changes in indices of mineral metabolism and bone turnover markers in HIV-infected children and adolescents receiving vitamin D and calcium supplement versus those receiving placebo 3. Evaluate if vitamin D stores are a determinant of bone mass in HIV infected children and adolescents receiving HAART. We hypothesize that vitamin D stores, as assessed by serum 25-hydroxyvitamin D levels, are an important determinant of bone mass in HIV-infected children and adolescents receiving HAART. We will test this hypothes
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT cholecalciferol plus calcium carbonate
Study Locations (1)
New York
- St.Luke's-Roosevelt Hospital Cener - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2003-07 |
| Est. Completion | 2006-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00724178
The ClinicalTrials.gov registry entry for NCT00724178 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (76% lower). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with HIV Infection appearing as the primary indexed condition, and to 1 intervention - of which cholecalciferol plus calcium carbonate is the first listed.
NCT00724178 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT00724178 about?
NCT00724178 is a clinical study titled "The Effect of Vitamin D and Calcium on Bone in Pediatric HIV". We have observed that vitamin D deficiency, as evidenced by low serum 25(OH)D concentrations, is common in children and adolescents with HIV infection. To determine whether vitamin D and calcium supplementation improve bone mineral content (BMC) and bone mineral density (BMD) in HIV-infected childre...
What is the current status of trial NCT00724178?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 59 participants. The study started on 2003-07. Estimated completion is 2006-12.
What conditions does trial NCT00724178 study?
This clinical trial studies the following conditions: HIV Infection, Bone Mass.
What interventions are being tested in trial NCT00724178?
The interventions under investigation include: cholecalciferol plus calcium carbonate (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00724178?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00724178 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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