Title | Vitamin D3 decreases parathyroid hormone in HIV-infected youth being treated with tenofovir: a randomized, placebo-controlled trial. |
Publication Type | Publication |
Year of Publication | 2012 |
Authors | Havens 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 Authors | Adolescent Medicine Trials Network(ATN) for HIV/AIDS Interventions 063 study team |
Journal | Clin Infect Dis |
Volume | 54 |
Issue | 7 |
Pagination | 1013-25 |
Date Published | 2012 Apr |
ISSN | 1537-6591 |
Keywords | Adenine, 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> |
DOI | 10.1093/cid/cir968 |
Alternate Journal | Clin Infect Dis |
PubMed ID | 22267714 |
PubMed Central ID | PMC3297650 |
Grant List | UL1-RR02517 / 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 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 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 |