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High Dose Vitamin D and Calcium for Bone Health in Individuals Initiating HAART

NCT01403051 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2018-10-12

Study results available
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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).

Conditions

  • HIV-1 Infection

Interventions

DRUG

EFV/FTC/TDF

FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.

DRUG

Calcium Carbonate

Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.

DRUG

Vitamin D3

One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.

DRUG

Placebo for calcium carbonate

A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks

DRUG

Placebo for vitamin D3

A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

    lead NETWORK

Principal Investigators

  • Edgar (Turner) Overton, MD · Alabama Therapeutics CRS

  • Michael T Yin, MD, MS · HIV Prevention & Treatment CRS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01403051 on ClinicalTrials.gov