Serum 25-hydroxyvitamin D response to vitamin D3 supplementation 50,000 IU monthly in youth with HIV-1 infection. J Clin Endocrinol Metab 2012 Nov;97(11):4004-13
Date
08/31/2012Pubmed ID
22933542Pubmed Central ID
PMC3485594DOI
10.1210/jc.2012-2600Scopus ID
2-s2.0-84868623121 (requires institutional sign-in at Scopus site) 42 CitationsAbstract
CONTEXT: 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.
OBJECTIVE: 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.
DESIGN, SETTING, AND PARTICIPANTS: 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.
INTERVENTION: 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.
RESULTS: 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.
CONCLUSIONS: 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.
Author List
Havens PL, Mulligan K, Hazra R, Flynn P, Rutledge B, Van Loan MD, Lujan-Zilbermann J, Kapogiannis BG, Wilson CM, Stephensen CB, Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 063 Study TeamMESH terms used to index this publication - Major topics in bold
AdolescentCholecalciferol
Double-Blind Method
Female
HIV Infections
HIV-1
Humans
Male
Treatment Outcome
Vitamin D
Vitamin D Deficiency
Vitamins
Young Adult
