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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: Completed Phase 2 study, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% higher). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
The efficacy endpoint is the percent change from baseline to week 48 in bone mineral density (BMD) at total hip (as measured by DXA scan)
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 |
What the finished NCT01403051 record still lists
NCT01403051 is an interventional study that assigns participants to a tested intervention. The registered 167 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% higher).
The record links to 0 conditions, and to 5 interventions - of which Vitamin D3 is the first listed.
NCT01403051 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01403051's enrollment target sits among peer trials
167 406th of 2000 higher than 1,595 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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