Vitamin D3 Supplementation Increases Spine Bone Mineral Density in Adolescents and Young Adults With Human Immunodeficiency Virus Infection Being Treated With Tenofovir Disoproxil Fumarate: A Randomized, Placebo-Controlled Trial.

TitleVitamin D3 Supplementation Increases Spine Bone Mineral Density in Adolescents and Young Adults With Human Immunodeficiency Virus Infection Being Treated With Tenofovir Disoproxil Fumarate: A Randomized, Placebo-Controlled Trial.
Publication TypePublication
Year of Publication2018
AuthorsHavens PL, Stephensen CB, Van Loan MD, Schuster GU, Woodhouse LR, Flynn PM, Gordon CM, Pan CG, Rutledge B, D Harris R, Price G, Baker A, Meyer WA, Wilson CM, Hazra R, Kapogiannis BG, Mulligan K
Corporate AuthorsAdolescent Medicine Trials Network for HIV/AIDS Interventions(ATN) 109 study team
JournalClin Infect Dis
Volume66
Issue2
Pagination220-228
Date Published2018 01 06
ISSN1537-6591
KeywordsAdolescent, Anti-HIV Agents, Bone Density, Bone Density Conservation Agents, Calcium-Regulating Hormones and Agents, Cholecalciferol, Double-Blind Method, Female, HIV Infections, Humans, Male, Placebos, Spine, Tenofovir, Treatment Outcome, Young Adult
Abstract

<p><b>Background: </b>Tenofovir disoproxil fumarate (TDF) decreases bone mineral density (BMD). We hypothesized that vitamin D3 (VITD3) would increase BMD in youth receiving TDF.</p><p><b>Methods: </b>This was a randomized, double-blind, placebo-controlled trial of directly observed VITD3 vs placebo every 4 weeks for 48 weeks in youth aged 16-24 years with HIV, RNA load <200 copies/mL, taking TDF-containing combination antiretroviral therapy (TDF-cART) for ≥180 days. Participants (N = 214) received a daily multivitamin containing VITD3 400 IU and calcium 162 mg, plus monthly randomized VITD3 50000 IU (n = 109) or placebo (n = 105). Outcome was change from baseline to week 48 in lumbar spine BMD (LSBMD). Data presented are median (Q1, Q3).</p><p><b>Results: </b>Participants were aged 22.0 (21.0, 23.0) years, 84% were male, and 74% were black/African American. At baseline, 62% had 25-hydroxy vitamin D (25-OHD) <20 ng/mL. Multivitamin adherence was 49% (29%, 69%), and VITD3/placebo adherence 100% (100%, 100%). Vitamin D intake was 2020 (1914, 2168) and 284 (179, 394) IU/day, and serum 25-OHD concentration was 36.9 (30.5, 42.4) and 20.6 (14.4, 25.8) ng/mL at 48 weeks in VITD3 and placebo groups, respectively (P < .001). From baseline to week 48, LSBMD increased by 1.15% (-0.75% to 2.74%) in the VITD3 group (n = 99; P < .001) and 0.09% (-1.49% to 2.61%) in the placebo group (n = 89; P = .25), without between-group difference (P = .12). VITD3 group changes occurred with baseline 25-OHD <20 ng/mL (1.17% [-.82% to 2.90%]; P = .004) and ≥20 ng/mL (0.93% [-.26% to 2.15%]; P = .033).</p><p><b>Conclusions: </b>For youth taking TDF-cART, LSBMD increased through 48 weeks with VITD3 plus multivitamin, but not with placebo plus multivitamin, independent of baseline vitamin D status.</p><p><b>Clinical Trials Registration: </b>NCT01751646.</p>

DOI10.1093/cid/cix753
Alternate JournalClin. Infect. Dis.
PubMed ID29020329
PubMed Central IDPMC5848310
Grant ListU01 HD040474 / HD / NICHD NIH HHS / United States
U01 HD040533 / HD / NICHD NIH HHS / United States