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NCT01403051 · ClinicalTrials.gov registry record · Phase 2
High Dose Vitamin D and Calcium for Bone Health in Individuals Initiating HAART
A Phase 2 study, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- Completed
- Registry status
- Phase 2
- Development phase
- 167
- Enrollment target
NCT01403051 is a Phase 2 study that has completed, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. The registered enrollment target is 167 participants.
The verdict
NCT01403051, a Phase 2 study, has completed, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 167 participants
- Enrollment target
Study Summary
This study was done with people who were infected with HIV and needed to start treatment for their HIV disease. The purpose of this study is to see if taking vitamin D and calcium will help prevent the bone loss that sometimes happens when people start HIV treatment. For this study, the following HIV treatment (or HAART) were provided in the form of a single tablet that contains three different drugs: efavirenz/emtricitabine/tenofovir (EFV/FTC/TDF). These drugs are approved by the FDA to treat HIV infection. The HIV treatment provided is common for people who are taking HIV drugs for the first time. The risks seen with this HIV treatment are the same that you would encounter when taking these drugs outside of the study. The lists of risks of this HIV treatment are included in this document because the drugs are provided by the study, not because the drugs are being tested. The purpose of the study is only to look at the impact of high doses of vitamin D and calcium in preventing bone loss. There are no study objectives related to HIV treatment (EFV/FTC/TDF).
Interventions
- DRUG Vitamin D3
- DRUG Calcium Carbonate
- DRUG EFV/FTC/TDF
- DRUG Placebo for calcium carbonate
- DRUG Placebo for vitamin D3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 167 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01403051
The ClinicalTrials.gov registry entry for NCT01403051 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 167 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Vitamin D3 is the first listed.
NCT01403051 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01403051 about?
NCT01403051 is a clinical study titled "High Dose Vitamin D and Calcium for Bone Health in Individuals Initiating HAART". This study was done with people who were infected with HIV and needed to start treatment for their HIV disease. The purpose of this study is to see if taking vitamin D and calcium will help prevent the bone loss that sometimes happens when people start HIV treatment. For this study, the following HI...
What is the current status of trial NCT01403051?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 167 participants. The study started on 2011-09. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01403051?
The interventions under investigation include: Vitamin D3 (DRUG), Calcium Carbonate (DRUG), EFV/FTC/TDF (DRUG), Placebo for calcium carbonate (DRUG), Placebo for vitamin D3 (DRUG).
Who is sponsoring clinical trial NCT01403051?
This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total clinical trials registered on ClinicalTrials.gov.
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