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Title:   Author  item
                                            HAVENS, PETER - Medical College Of Wisconsinitem
                                            MULLIGAN, KATHLEEN - University Of Californiaitem
                                            HAZRA, ROHAN - National Institutes Of Health (NIH)item
                                            FLYNN, PATRICIA - St Jude Children’s Research Hospitalitem
                                            RUTLEDGE, BRANDY - Westat Incitem
                                            Van Loan, Martaitem
                                            LUJAN-ZILBERMAN, JORGE - University Of South Floridaitem
                                            KAPOGIANNIS, BILL - National Institutes Of Health (NIH)item
                                            WILSON, CRAIG - University Of Alabamaitem
                                            Stephensen, Charles
  Submitted to: Journal of Clinical Endocrinology and Metabolism
                                    Publication Type: Peer Reviewed Journal
                                    Publication Acceptance Date: 8/9/2012
                                    Publication  Date: 8/29/2012
                                    Citation: Havens, P.L., Mulligan, K., Hazra, R., Flynn, P., Rutledge, B., Van Loan, M.D., Lujan-Zilberman, J., Kapogiannis, B.G., Wilson, C.M., Stephensen, C.B. 2012. Serum 25-hydroxyvitamin D response to vitamin D3 supplementation 50,000 IU monthly in youth with HIV-1 infection. Journal of Clinical Endocrinology and Metabolism. 97(11):0000-0000. DOI:10.1210/jc.2012-2600.Interpretive Summary: Vitamin D deficiency is common in youth with HIV infection, particularly among those receiving the antiretroviral drug efavirenz. Optimal vitamin D dosing for treatment of vitamin D deficiency in HIV may differ from dosing in uninfected individuals.  Our goals in this study were to (1) measure change in vitamin D status, as indicated by change in serum 25-hydroxy vitamin D (25-OHD) concentration, during treatment with vitamin D3 for 12 wk (50,000 IU every 4 wk; directly observed-therapy) and (2) to evaluate safety by monitoring urinary calcium excretion (a correlate of excessive calcium absorption, which may be triggered by excessive vitamin D intake).  This study was a randomized double-blind, placebo-controlled multicenter trial of HIV-infected youth ages 18-24 years on stable antiretroviral therapy.  Of 203 eligible participants, 169 complete the full study.  At baseline, the mean age was 21 yr, 37% were female and 52% African American, and 54% were vitamin D insufficient (serum 25-OHD < 20 ng/mL).  Ninety-five percent of the subjects receiving vitamin D were vitamin D sufficient by the end of the study. Vitamin D supplementation increased mean 25-OHD serum concentration from 22 (baseline) to 36 ng/mL at week 12 (p<0.001) with no change for the group receiving placebo.  While efavirenz treatment was associated with lower baseline 25-OHD serum concentration, efavirenz treatment did not diminish the response to vitamin D supplementation. There was no treatment-related toxicity.  In summary, supplementation with vitamin D3 50,000 IU monthly for 3 doses was safe and reduced the prevalence of vitamin D deficiency and insufficiency to 5% in treated participants regardless of antiretroviral regimen.
                                Technical Abstract: 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: Measure change in 25-hydroxy vitamin D (25-OHD) concentration from baseline to study weeks 4 and 12 during treatment with vitamin D3, 50,000 IU monthly; and evaluate safety.

Design, setting, and participants: Randomized double-blind, placebo-controlled multicenter trial of HIV-infected youth ages 18-24 years, viral load <5,000 copies/mL, on stable antiretroviral therapy.

Intervention: Vitamin D3 50,000 IU, or matching placebo capsule, administered in three directly observed oral doses at 4-week intervals.

Results: Of 203 participants, 169 evaluable participants had complete follow-up.  At baseline, mean (SD) age was 20.9 (2.0) years; 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 administered vitamin D, 95% had > sufficient 25-OHD by week 12. Vitamin D supplementation increased mean (SD) 25-OHD serum concentration from baseline 21.9 (13.3) to 35.9 (19.1) ng/mL at week 12 (p<0.001) with no change for placebo.  While efavirenz treatment was associated with lower baseline 25-OHD serum 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 3 doses was safe and reduced the prevalence of vitamin D deficiency and insufficiency to 5% in treated participants regardless of antiretroviral regimen.


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