Vitamin D3 decreases parathyroid hormone in HIV-infected youth being treated with tenofovir: a randomized, placebo-controlled trial.

TitleVitamin D3 decreases parathyroid hormone in HIV-infected youth being treated with tenofovir: a randomized, placebo-controlled trial.
Publication TypePublication
Year of Publication2012
AuthorsHavens PL, Stephensen CB, Hazra R, Flynn PM, Wilson CM, Rutledge B, Bethel J, Pan CG, Woodhouse LR, Van Loan MD, Liu N, Lujan-Zilbermann J, Baker A, Kapogiannis BG, Mulligan K
Corporate AuthorsAdolescent Medicine Trials Network(ATN) for HIV/AIDS Interventions 063 study team
JournalClin Infect Dis
Volume54
Issue7
Pagination1013-25
Date Published2012 Apr
ISSN1537-6591
KeywordsAdenine, Adolescent, Anti-HIV Agents, Antiretroviral Therapy, Highly Active, Cholecalciferol, Double-Blind Method, Drug Interactions, Female, HIV Infections, Humans, Male, Multicenter Studies as Topic, Organophosphonates, Parathyroid Hormone, Placebos, Tenofovir, Vitamins, Young Adult
Abstract

<p><b>BACKGROUND: </b>The study goal was to determine the effect of vitamin D (VITD) supplementation on tubular reabsorption of phosphate (TRP), parathyroid hormone (PTH), bone alkaline phosphatase (BAP), and C-telopeptide (CTX) in youth infected with human immunodeficiency virus (HIV) receiving and not receiving combination antiretroviral therapy (cART) containing tenofovir disoproxil fumarate (TDF).</p><p><b>METHODS: </b>This randomized, double-blind, placebo-controlled multicenter trial enrolled HIV-infected youth 18-25 years based on stable treatment with cART containing TDF (n = 118) or no TDF (noTDF; n = 85), and randomized within those groups to vitamin D3, 50 000 IU (n = 102) or placebo (n = 101), administered at 0, 4, and 8 weeks. Outcomes included change in TRP, PTH, BAP, and CTX from baseline to week 12 by TDF/noTDF; and VITD/placebo.</p><p><b>RESULTS: </b>At baseline, VITD and placebo groups were similar except those on TDF had lower TRP and higher PTH and CTX. At week 12, 95% in the VITD group had sufficient serum 25-hydroxy vitamin D (25-OHD; ≥20 ng/mL), increased from 48% at baseline, without change in placebo (P < .001). PTH decreased in the TDF group receiving VITD (P = .031) but not in the noTDF group receiving VITD, or either placebo group. The decrease in PTH with VITD in those on TDF occurred with insufficient and sufficient baseline 25-OHD (mean PTH change, -7.9 and -6.2 pg/mL; P = .031 and .053, respectively).</p><p><b>CONCLUSIONS: </b>In youth on TDF, vitamin D3 supplementation decreased PTH, regardless of baseline 25-OHD concentration.</p><p><b>CLINICAL TRIALS REGISTRATION: </b>NCT00490412.</p>

DOI10.1093/cid/cir968
Alternate JournalClin. Infect. Dis.
PubMed ID22267714
PubMed Central IDPMC3297650
Grant ListUL1-RR02517 / RR / NCRR NIH HHS / United States
U01 HD 040533 / HD / NICHD NIH HHS / United States
UL1-RR025014 / RR / NCRR NIH HHS / United States
U01 HD040533 / HD / NICHD NIH HHS / United States
U01 HD 040474 / HD / NICHD NIH HHS / United States
U01 HD040474 / HD / NICHD NIH HHS / United States
M01-RR10710 / RR / NCRR NIH HHS / United States
M01-RR00188 / RR / NCRR NIH HHS / United States
U01 HD040497 / HD / NICHD NIH HHS / United States
M01 RR000188 / RR / NCRR NIH HHS / United States
UL1 RR024131 / RR / NCRR NIH HHS / United States
M01 RR010710 / RR / NCRR NIH HHS / United States
UL1 RR025014 / RR / NCRR NIH HHS / United States
U01 A1068632 / / PHS HHS / United States
UL1-RR-024134 / RR / NCRR NIH HHS / United States
M01RR020359 / RR / NCRR NIH HHS / United States
UL1 RR024134 / RR / NCRR NIH HHS / United States
M01 RR020359 / RR / NCRR NIH HHS / United States