Serum 25-Hydroxyvitamin D Response to Vitamin D3 Supplementation 50,000 IU Monthly in Youth with HIV-1 Infection
The Journal of Clinical Endocrinology & Metabolism August 29, 2012 jc.2012-2600
Peter L. Havens, Kathleen Mulligan, Rohan Hazra, Patricia Flynn, Brandy Rutledge, Marta D. Van Loan, Jorge Lujan-Zilbermann, Bill G. Kapogiannis, Craig M. Wilson, Charles B. Stephensen and the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 063 Study Team
Children’s Research Institute (P.L.H.), Medical College of Wisconsin, Children’s Hospital of Wisconsin, Milwaukee, Wisconsin 53201; University of California at San Francisco (K.M.), San Francisco, California 94110; Eunice Kennedy Shriver National Institute of Child Health and Human Development (R.H., B.G.K.), Bethesda, Maryland 20892; St. Jude Children’s Research Hospital (P.F.), Memphis, Tennessee 38105; Westat (B.R.), Rockville, Maryland 20850; United States Department of Agriculture Agricultural Research Service (M.D.V.L., C.B.S.), Western Human Nutrition Research Center, Davis, California 95616; University of South Florida College of Medicine (J.L.-Z.), Tampa, Florida 33606; and University of Alabama at Birmingham (C.M.W.), Birmingham, Alabama 35294
Address all correspondence and requests for reprints to: Peter L. Havens, M.S., M.D., Pediatric Infectious Diseases, Suite C450, P.O. Box 1997, Milwaukee, Wisconsin 53201-1997. E-mail: phavens at mcw.edu.
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 D3, 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 D3, 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 D3 50,000 IU monthly for three doses was safe. Increases in 25-OHD occurred in treated participants regardless of antiretroviral regimen.
Received June 25, 2012; Accepted August 9, 2012; Copyright © 2012 by The Endocrine Society
- 46% were > 20 ng/ml initially
- 94% were > 20 ng/ml at 3 months
- Since there is no indication otherwise, we assume that the vitamin D measurements were taken on the same day as the 3rd dose.
- We will guess that by 2 weeks after the final dose that 94% ==> 96%.
- No mention about season. Did it happen that the 3rd month was during the summer/fall when the vitamin D levels will be higher?
- Overview HIV and vitamin D
- Overview How Much vitamin D many people believe that vitamin D levels should be > 30 nanograms