Vitamin D3 Decreases Parathyroid Hormone in HIV-Infected Youth Being Treated With Tenofovir: A Randomized, Placebo-Controlled Trial

• Published in: Clinical infectious diseases Vol. 54; no. 7; pp. 1013 - 1025
• Main Authors: Havens, Peter L., Stephensen, Charles B., Hazra, Rohan, Flynn, Patricia M., Wilson, Craig M., Rutledge, Brandy, Bethel, James, Pan, Cynthia G., Woodhouse, Leslie R., Van Loan, Marta D., Liu, Nancy, Lujan-Zilbermann, Jorge, Baker, Alyne, Kapogiannis, Bill G., Mulligan, Kathleen
• Format: Journal Article
• Language: English
• Published: Oxford Oxford University Press 01-04-2012
• Subjects: Acute kidney tubular necrosis; Adenine - administration & dosage; Adenine - analogs & derivatives; Adolescent; Anti-HIV Agents - administration & dosage; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiretroviral drugs; Antiretroviral Therapy, Highly Active - methods; Antiretrovirals; Antiviral agents; Biological and medical sciences; Bones; Calcium; Cholecalciferol - administration & dosage; Clinical trials; Double-Blind Method; Drug Interactions; Female; Glomerular filtration rate; HIV; HIV Infections - drug therapy; HIV/AIDS; Hormones; Human immunodeficiency virus; Human viral diseases; Humans; Immunodeficiencies; Immunodeficiencies. Immunoglobulinopathies; Immunopathology; Infectious diseases; Male; Medical sciences; Multicenter Studies as Topic; Organophosphonates - administration & dosage; Parathyroid Hormone - blood; Pediatrics; Pharmacology. Drug treatments; Phosphates; Placebos; Placebos - administration & dosage; Tenofovir; Urine; Viral diseases; Viral diseases of the lymphoid tissue and the blood. Aids; Vitamin D; Vitamins - administration & dosage; Young Adult; Immunopathology; Purine nucleotide; Antiretroviral agent; Acyclic nucleotide; RNA-directed DNA polymerase; Enzyme; Transferases; Peptide hormone; Enzyme inhibitor; AIDS; Organic phosphonate; Nucleotide analog; Immune deficiency; Infection; Tenofovir; Nucleotidyltransferases; Treatment; Parathyroid hormone; Reverse transcriptase inhibitor; Viral disease; Nucleoside analog; Antiviral
• ISSN: 1058-4838; 1537-6591
• DOI: 10.1093/cid/cir968

Background. 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). Methods. 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. Results. 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). Conclusions. In youth on TDF, vitamin D3 supplementation decreased PTH, regardless of baseline 25-OHD concentration. Clinical Trials Registration. NCT00490412.