Serum 25-hydroxyvitamin D response to vitamin D3 supplementation 50,000 IU monthly in youth with HIV-1 infection.

TitleSerum 25-hydroxyvitamin D response to vitamin D3 supplementation 50,000 IU monthly in youth with HIV-1 infection.
Publication TypePublication
Year of Publication2012
AuthorsHavens PL, Mulligan K, Hazra R, Flynn P, Rutledge B, Van Loan MD, Lujan-Zilbermann J, Kapogiannis BG, Wilson CM, Stephensen CB
Corporate AuthorsAdolescent Medicine Trials Network for HIV/AIDS Interventions(ATN) 063 Study Team
JournalJ Clin Endocrinol Metab
Volume97
Issue11
Pagination4004-13
Date Published2012 Nov
ISSN1945-7197
KeywordsAdolescent, Cholecalciferol, Double-Blind Method, Female, HIV Infections, HIV-1, Humans, Male, Treatment Outcome, Vitamin D, Vitamin D Deficiency, Vitamins, Young Adult
Abstract

<p><b>CONTEXT: </b>Vitamin D deficiency and insufficiency occur frequently in youth with HIV infection, particularly among those receiving the antiretroviral drug efavirenz. Optimal vitamin D dosing for treatment is unclear.</p><p><b>OBJECTIVE: </b>Our objective was to evaluate safety and measure change in 25-hydroxyvitamin D (25-OHD) concentration from baseline to study wk 4 and 12 during treatment with vitamin D(3), 50,000 IU monthly.</p><p><b>DESIGN, SETTING, AND PARTICIPANTS: </b>We conducted a randomized double-blind, placebo-controlled multicenter trial of HIV-infected youth ages 18-24 yr, with viral load below 5000 copies/ml, on stable antiretroviral therapy.</p><p><b>INTERVENTION: </b>INTERVENTION included vitamin D(3), 50,000 IU (n = 102), or matching placebo (n = 101) administered in three directly observed oral doses at monthly intervals.</p><p><b>RESULTS: </b>At baseline, mean (sd) age was 20.9 (2.0) yr; 37% were female and 52% African-American, and 54% were vitamin D deficient/insufficient (25-OHD < 20 ng/ml), with no randomized group differences. Of evaluable participants vitamin D deficient/insufficient at baseline who were administered vitamin D, 43 of 46 (93%) had sufficient 25-OHD by wk 12. Vitamin D supplementation increased 25-OHD serum concentration from a baseline of 21.9 (13.3) to 35.9 (19.1) ng/ml at wk 12 (P < 0.001) with no change for placebo. Although use of the antiretroviral efavirenz was associated with lower baseline 25-OHD concentration, efavirenz did not diminish the response to vitamin D supplementation. There was no treatment-related toxicity.</p><p><b>CONCLUSIONS: </b>Supplementation with vitamin D(3) 50,000 IU monthly for three doses was safe. Increases in 25-OHD occurred in treated participants regardless of antiretroviral regimen.</p>

DOI10.1210/jc.2012-2600
Alternate JournalJ. Clin. Endocrinol. Metab.
PubMed ID22933542
PubMed Central IDPMC3485594
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 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
M01RR020359 / RR / NCRR NIH HHS / United States
UL1 RR024134 / RR / NCRR NIH HHS / United States
M01 RR020359 / RR / NCRR NIH HHS / United States