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

Academic Article

Abstract

  • © The Author(s) 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com. Background Tenofovir disoproxil fumarate (TDF) decreases bone mineral density (BMD). We hypothesized that Vitamin D3 (VITD3) would increase BMD in youth receiving TDF. Methods 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). Results 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). Conclusions 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. Clinical Trials Registration NCT01751646.
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    Author List

  • Havens PL; Stephensen CB; Van Loan MD; Schuster GU; Woodhouse LR; Flynn PM; Gordon CM; Pan CG; Rutledge B; Harris DR
  • Start Page

  • 220
  • End Page

  • 228
  • Volume

  • 66
  • Issue

  • 2