High Dose Vitamin D and Calcium for Bone Health in Individuals Initiating HAART
Public ClinicalTrials.gov record NCT01403051. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Randomized, Double-Blind Phase II Trial of High-Dose Vitamin D and Calcium for Bone Health in HIV-Infected Individuals Initiating Highly Active Antiretroviral Therapy (HAART)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT01403051
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 167 participants
Conditions and interventions
Conditions
Interventions
- EFV/FTC/TDF Drug
- Calcium Carbonate Drug
- Vitamin D3 Drug
- Placebo for calcium carbonate Drug
- Placebo for vitamin D3 Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2011
- Primary completion
- Jan 31, 2013
- Completion
- Jan 31, 2013
- Last update posted
- Oct 11, 2018
2011 – 2013
United States locations
- U.S. sites
- 38
- U.S. states
- 18
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Therapeutics CRS (5801) | Birmingham | Alabama | 35294 | — |
| Usc Crs (1201) | Los Angeles | California | 90033 | — |
| UCLA CARE Center CRS (601) | Los Angeles | California | 90095 | — |
| Stanford CRS (501) | Palo Alto | California | 94304 | — |
| Ucsd, Avrc Crs (701) | San Diego | California | 92103 | — |
| Ucsf Aids Crs (801) | San Francisco | California | 94110 | — |
| Harbor-UCLA Med. Ctr. CRS (603) | Torrance | California | 90502 | — |
| University of Colorado Hospital CRS (6101) | Aurora | Colorado | 80045 | — |
| Georgetown University CRS (GU CRS) (1008) | Washington D.C. | District of Columbia | 20007 | — |
| The Ponce de Leon Ctr. CRS (5802) | Atlanta | Georgia | 30308 | — |
| Northwestern University CRS (2701) | Chicago | Illinois | 60611 | — |
| Rush University Medical Center (2702) | Chicago | Illinois | 60612 | — |
| IHV Baltimore Treatment CRS (4651) | Baltimore | Maryland | 21201 | — |
| Massachusetts General Hospital ACTG CRS (101) | Boston | Massachusetts | 02114 | — |
| Brigham and Women's Hosp. ACTG CRS (107) | Boston | Massachusetts | 02115 | — |
| Beth Israel Deaconess Med. Ctr., ACTG CRS (103) | Boston | Massachusetts | 02215 | — |
| Washington University CRS (2101) | St Louis | Missouri | 63110 | — |
| New Jersey Medical School-Adult Clinical Research Ctr. CRS (31477) | Newark | New Jersey | 07103 | — |
| Cornell CRS (7804) | New York | New York | 10011 | — |
| NY Univ. HIV/AIDS CRS (401) | New York | New York | 10016 | — |
| HIV Prevention & Treatment CRS (30329) | New York | New York | 10032 | — |
| AIDS Care CRS (1108) | Rochester | New York | 14642 | — |
| University of Rochester ACTG CRS (1101) | Rochester | New York | 14642 | — |
| Bronx-Lebanon Hosp. Ctr. CRS (31469) | The Bronx | New York | 10457 | — |
| Unc Aids Crs (3201) | Chapel Hill | North Carolina | 27514 | — |
| Duke University Medical Center Adult CRS (1601) | Durham | North Carolina | 27710 | — |
| Regional Center for Infectious Disease, Wendover Medical Center CRS (3203) | Greensboro | North Carolina | 27401 | — |
| Univ. of Cincinnati CRS (2401) | Cincinnati | Ohio | 45267 | — |
| Case CRS (2501) | Cleveland | Ohio | 44106 | — |
| MetroHealth CRS (2503) | Cleveland | Ohio | 44109 | — |
| The Ohio State Univ. AIDS CRS (2301) | Columbus | Ohio | 43210 | — |
| Hosp. of the Univ. of Pennsylvania CRS (6201) | Philadelphia | Pennsylvania | 19104 | — |
| Pittsburgh CRS (1001) | Pittsburgh | Pennsylvania | 15213 | — |
| The Miriam Hosp. ACTG CRS (2951) | Providence | Rhode Island | 02906 | — |
| Vanderbilt Therapeutics CRS (3652) | Nashville | Tennessee | 37232 | — |
| Trinity Health and Wellness Center CRS (31443) | Dallas | Texas | 75208 | — |
| Houston AIDS Research Team CRS (31473) | Houston | Texas | 77030 | — |
| University of Washington AIDS CRS (1401) | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01403051, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 11, 2018 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01403051 live on ClinicalTrials.gov.