Skip Navigation LinksHome > February 2015 - Volume 34 - Issue 2 > High-dose Vitamin D3 Supplementation in Children and Young A...
Pediatric Infectious Disease Journal:
doi: 10.1097/INF.0000000000000483
HIV Reports

High-dose Vitamin D3 Supplementation in Children and Young Adults with HIV: A Randomized, Placebo-controlled Trial

Stallings, Virginia A. MD*†; Schall, Joan I. PhD*; Hediger, Mary L. PhD*; Zemel, Babette S. PhD*†; Tuluc, Florin PhD†‡; Dougherty, Kelly A. PhD*†; Samuel, Julia L. BS*; Rutstein, Richard M. MD†§

Collapse Box

Abstract

Background: Suboptimal vitamin D status is prevalent in HIV-infected patients and associated with increased risk of disease severity and morbidity. We aimed to determine 12-month safety and efficacy of daily 7000 IU vitamin D3 (vitD3) versus placebo to sustain increased serum 25-hydroxyvitamin D (25(OH)D) and improve immune status in HIV-infected subjects.

Methods: This was a double-blind trial of perinatally acquired HIV (PHIV)-infected subjects or behaviorally acquired HIV (BHIV)-infected subjects (5.0-24.9 years). Safety, 25(OH)D-related parameters and immune status were assessed at baseline, 3, 6 and 12 months.

Results: Fifty-eight subjects enrolled (67% male, 85% African American and 64% BHIV) and 50 completed with no safety concerns. In unadjusted analyses, there were no differences between randomization groups at baseline; at 3, 6 and 12 months, 25(OH)D was higher with supplementation than baseline and higher than with placebo (P < 0.05). In adjusted mixed models, in the supplementation group, the fixed effect of 25(OH)D was higher (P < 0.001). Percentage of naive T-helper cells (Th naive%) were significantly (P < 0.01) and T-helper cells (CD4%) marginally (P < 0.10) increased with supplementation in those taking highly active antiretroviral therapy (HAART), and RNA viral load was reduced (P ≤ 0.05). In exploratory linear models, change in 25(OH)D predicted RNA viral load at 3 and 12 months and CD4% at 3 months (P < 0.05).

Conclusions: Daily 7000 IU vitD3 for 12 months was safe in HIV-infected subjects and effective in increasing 25(OH)D. Supplementation improved some clinically important HIV immune markers in subjects on HAART. Adjunct therapy with high-dose, daily vitD3 for HIV-infected subjects and for those on/off HAART requires further investigation.

Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.

Login

Article Level Metrics

Search for Similar Articles
You may search for similar articles that contain these same keywords or you may modify the keyword list to augment your search.