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. 2014 Dec;3(4):294-303.
doi: 10.1093/jpids/piu012. Epub 2014 Mar 27.

Safety and Efficacy of High-Dose Daily Vitamin D3 Supplementation in Children and Young Adults Infected With Human Immunodeficiency Virus

Kelly A Dougherty  1 , Joan I Schall  2 , Babette S Zemel  1 , Florin Tuluc  3 , Xiaoling Hou  4 , Richard M Rutstein  5 , Virginia A Stallings  1
Affiliations

Safety and Efficacy of High-Dose Daily Vitamin D3 Supplementation in Children and Young Adults Infected With Human Immunodeficiency Virus

Kelly A Dougherty et al. J Pediatric Infect Dis Soc. 2014 Dec.

Abstract

Background: Suboptimal vitamin D (vitD) status is common in children and young adults infected with human immunodeficiency virus (HIV). The vitD supplemental dose needed to normalize vitD status in this population is unknown.

Methods: In this double-blind trial, subjects infected with HIV ages 8.3 to 24.9 years were randomized to vitD3 supplementation of 4000 IU/day or 7000 IU/day and evaluated at 6 and 12 week for changes in vitD status and HIV indicators. A dose was considered unsafe if serum calcium was elevated (above age and sex-specific range) associated with elevated serum 25 hydroxyvitamin D (25(OH)D); >160 ng/mL).

Results: At baseline, 95% of subjects (n = 44; 43% with perinatally acquired HIV, 57% with behaviorally acquired HIV) had a suboptimal serum 25(OH)D concentration of <32 ng/mL (mean ± standard deviation, 19.3 ± 7.4; range, 4.4-33.6 ng/mL). After 12 weeks (main outcome) of D3 supplementation, both D3 doses were safe and well tolerated, with no evidence of elevation of serum calcium concentrations or deterioration in HIV immunologic or virologic status. Sufficient vitD status, defined as serum 25(OH)D ≥32 ng/mL, was achieved in 81% of all subjects, and only the 7000 IU/day group (86%) achieved this a priori efficacy criterion in >80% of subjects. Change in serum 25(OH)D did not differ between HIV acquisition groups.

Conclusions: A 7000 IU/day D3 supplementation was safe and effective in children and young adults infected with HIV.

Trial registration: ClinicalTrials.gov NCT01092338.

Keywords: HIV; nutrition; pediatrics; supplementation; vitamin D..

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Figures

Figure 1.
Figure 1.
Flow diagram of group assignment and follow up.
See this image and copyright information in PMC

References

    1. Arpadi SM, McMahon D, Abrams EJ, et al. Effect of bimonthly supplementation with oral cholecalciferol on serum 25-hydroxyvitamin D concentrations in HIV-infected children and adolescents. Pediatrics. 2009;123:e121–6. - PMC - PubMed
    1. Stephensen CB, Marquis GS, Kruzich LA, et al. Vitamin D status in adolescents and young adults with HIV infection. Am J Clin Nutr. 2006;83:1135–41. - PubMed
    1. Rutstein R, Downes A, Zemel B, et al. Vitamin D status in children and young adults with perinatally acquired HIV infection. Clin Nutr. 2011;30:624–8. - PubMed
    1. Eckard AR, Judd SE, Ziegler TR, et al. Risk factors for vitamin D deficiency and relationship with cardiac biomarkers, inflammation and immune restoration in HIV-infected youth. Antivir Ther. 2012;17:1069–78. - PMC - PubMed
    1. Haug C, Muller F, Aukrust P, Froland SS. Subnormal serum concentration of 1,25-vitamin D in human immunodeficiency virus infection: correlation with degree of immune deficiency and survival. J Infect Dis. 1994;169:889–93. - PubMed

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