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.
From the *Division of Gastroenterology, Hepatology and Nutrition, Children’s Hospital of Philadelphia; †Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania; ‡Allergy and Immunology; and §General Pediatrics, Children’s Hospital of Philadelphia, Philadelphia, PA.
Accepted for publication June 22, 2014.
This work was supported by the NIH/National Center for Complementary and Alternative Medicine, Grant R01AT005531, the National Center for Research Resources, Grant UL1RR024134, and is now at the National Center for Advancing Translational Sciences, Grant UL1TR000003. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. This publication was made possible through core services and support from the University of Pennsylvania Center for AIDS Research (CFAR), an NIH-funded program (P30AI045008). Additional support was from the Jean A. Cortner Endowed Chair, Nutrition Center and the Research Institute at the Children’s Hospital of Philadelphia. Life Extension (Ft. Lauderdale, FL) and J.R. Carlson Laboratories, Inc. (Arlington Heights, IL) donated the vitamin D3 supplements and placebo capsules and drops, respectively.
The authors have no other funding or conflicts of interest to disclose.
Address for correspondence: Virginia A. Stallings, MD, Division of Gastroenterology, Hepatology and Nutrition, Children’s Hospital of Philadelphia, 3535 Market Street, Room 1558, Philadelphia, PA 19104. E-mail: firstname.lastname@example.org.