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

Peter L. Havens, Charles B. Stephensen, Marta D. Van Loan, Gertrud U. Schuster, Leslie R. Woodhouse, Patricia M. Flynn, Catherine M. Gordon, Cynthia G. Pan, Brandy Rutledge, D. Robert Harris, Georgine Price, Alyne Baker, William A. Meyer, Craig M. Wilson, Rohan Hazra, Bill G. Kapogiannis, Kathleen Mulligan, Kavya Vellala, Justin Wheeler, Roger FieldingTammy Freytag, Joseph Domek, Erik Gertz, Patricia Emmanuel, Diane Straub, Elizabeth Enriquez-Bruce, Marvin Belzer, Diane Tucker, Larry D'Angelo, Connie Trexler, Steve Douglas, Mary Tanney, John H. Stroger, Miguel Martinez, Lisa Henry-Reid, Kelly Bojan, Donna Futterman, Maria Campos, Sue Ellen Abdalian, Leslie Kozina, Larry Friedman, Donna Maturo, Aditya Guar, Mary Dillard, Mary Paul, Jane Head, Liz Secord, Angulique Outlaw, Charnell Cromer, Allison Agwu, Renata Sanders, Thuy Anderson, Ken Mayer, Julian Dormitzer, Dan Reirden, Carrie Chambers, Andrea Kovacs, Eva Operskalski, James Homans, Allison Bearden, Susie Sanchez, Ana Puga, Zulma Eysallenne, Midnela Acevedo, Nicolas Rosario, Lourdes Angeli Nieves, Andrew Wiznia, Jacobo Abadi, Michael Rosenberg, Joanna Dobroszycki, Marlene Burey

Research output: Contribution to journalArticle

14 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)220-228
Number of pages9
JournalClinical Infectious Diseases
Volume66
Issue number2
DOIs
StatePublished - Jan 15 2018

Keywords

  • HIV infection
  • Vitamin D supplementation
  • bone mineral density
  • parathyroid hormone
  • tenofovir disoproxil fumarate

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

Fingerprint Dive into the research topics of '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'. Together they form a unique fingerprint.

  • Cite this

    Havens, P. L., Stephensen, C. B., Van Loan, M. D., Schuster, G. U., Woodhouse, L. R., Flynn, P. M., Gordon, C. M., Pan, C. G., Rutledge, B., Harris, D. R., Price, G., Baker, A., Meyer, W. A., Wilson, C. M., Hazra, R., Kapogiannis, B. G., Mulligan, K., Vellala, K., Wheeler, J., ... Burey, M. (2018). 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. Clinical Infectious Diseases, 66(2), 220-228. https://doi.org/10.1093/cid/cix753