At a glance
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A Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Effectiveness of Vitamin D3 50,000 IU Every 4 Weeks to Increase Bone Mineral Density and Decrease Tenofovir-Induced Hyperparathyroidism in Youth With HIV Infection Being Treated With Tenofovir-Containing Combination Antiretroviral Therapy (cART)
In Brief
A clinical study evaluating Vitamin D3 50,000 IU and Vitamin D3 placebo for HIV Infection. Completed, enrolled 214 participants across 17 sites in 2 countries.
Detailed Summary
This is a 48 week randomized double-blind, placebo-controlled prospective cohort study of adolescents and young adults with HIV infection in the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) who are currently being treated with cART that includes tenofovir disoproxil fumarate (TDF) as one component of the regimen that includes at least three Food and Drug Administration (FDA)-approved antiretroviral (ARV) drugs for at least 180 days.
Study Details
Timeline
Interventions
Group A: Vitamin D3 50,000 IU orally every four weeks by DOT
Group B: Vitamin D3 placebo orally every four weeks by DOT