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: 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 D 3 50,000 IU monthly for three doses was safe. Increases in 25-OHD occurred in treated participants regardless of antiretroviral regimen.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 4004-4013 |
| Number of pages | 10 |
| Journal | Journal of Clinical Endocrinology and Metabolism |
| Volume | 97 |
| Issue number | 11 |
| DOIs | |
| State | Published - Nov 2012 |
| Externally published | Yes |
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ASJC Scopus subject areas
- Biochemistry
- Clinical Biochemistry
- Endocrinology
- Biochemistry, medical
- Endocrinology, Diabetes and Metabolism
Cite this
Serum 25-hydroxyvitamin D response to vitamin D3 supplementation 50,000 IU monthly in youth with HIV-1 infection. / Havens, Peter L.; Mulligan, Kathleen; Hazra, Rohan; Flynn, Patricia; Rutledge, Brandy; Van Loan, Marta D.; Lujan-Zilbermann, Jorge; Kapogiannis, Bill G.; Wilson, Craig M.; Stephensen, Charles B.; Emmanuel, [No Value]; Lujan-Zilberman, [No Value]; Julian, [No Value]; Belzer, [No Value]; Flores, [No Value]; Tucker, [No Value]; Kovacs, [No Value]; Homans, [No Value]; Lozano, [No Value]; D'Angelo, [No Value]; Hagler, [No Value]; Trexler, [No Value]; Douglas, [No Value]; Tanney, [No Value]; DiBenedetto, [No Value]; Martinez, [No Value]; Bojan, [No Value]; Jackson, [No Value]; Febo, [No Value]; Ayala-Flores, [No Value]; Fuentes-Gomez, [No Value]; Futterman, [No Value]; Enriquez-Bruce, [No Value]; Campos, [No Value]; Steever, [No Value]; Geiger, [No Value]; Moscicki, [No Value]; Auerswald, [No Value]; Irish, [No Value]; Abdalian, [No Value]; Kozina, [No Value]; Baker, [No Value]; Peralta, [No Value]; Gorle, [No Value]; Friedman, [No Value]; Maturo, [No Value]; Major-Wilson, [No Value]; Puga, [No Value]; Leonard, [No Value]; Inman, [No Value]; Flynn, [No Value]; Dillard, [No Value]; Garofalo, [No Value]; Brennan, [No Value]; Flanagan, [No Value].
In: Journal of Clinical Endocrinology and Metabolism, Vol. 97, No. 11, 11.2012, p. 4004-4013.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Serum 25-hydroxyvitamin D response to vitamin D3 supplementation 50,000 IU monthly in youth with HIV-1 infection
AU - Havens, Peter L.
AU - Mulligan, Kathleen
AU - Hazra, Rohan
AU - Flynn, Patricia
AU - Rutledge, Brandy
AU - Van Loan, Marta D.
AU - Lujan-Zilbermann, Jorge
AU - Kapogiannis, Bill G.
AU - Wilson, Craig M.
AU - Stephensen, Charles B.
AU - Emmanuel, [No Value]
AU - Lujan-Zilberman, [No Value]
AU - Julian, [No Value]
AU - Belzer, [No Value]
AU - Flores, [No Value]
AU - Tucker, [No Value]
AU - Kovacs, [No Value]
AU - Homans, [No Value]
AU - Lozano, [No Value]
AU - D'Angelo, [No Value]
AU - Hagler, [No Value]
AU - Trexler, [No Value]
AU - Douglas, [No Value]
AU - Tanney, [No Value]
AU - DiBenedetto, [No Value]
AU - Martinez, [No Value]
AU - Bojan, [No Value]
AU - Jackson, [No Value]
AU - Febo, [No Value]
AU - Ayala-Flores, [No Value]
AU - Fuentes-Gomez, [No Value]
AU - Futterman, [No Value]
AU - Enriquez-Bruce, [No Value]
AU - Campos, [No Value]
AU - Steever, [No Value]
AU - Geiger, [No Value]
AU - Moscicki, [No Value]
AU - Auerswald, [No Value]
AU - Irish, [No Value]
AU - Abdalian, [No Value]
AU - Kozina, [No Value]
AU - Baker, [No Value]
AU - Peralta, [No Value]
AU - Gorle, [No Value]
AU - Friedman, [No Value]
AU - Maturo, [No Value]
AU - Major-Wilson, [No Value]
AU - Puga, [No Value]
AU - Leonard, [No Value]
AU - Inman, [No Value]
AU - Flynn, [No Value]
AU - Dillard, [No Value]
AU - Garofalo, [No Value]
AU - Brennan, [No Value]
AU - Flanagan, [No Value]
PY - 2012/11
Y1 - 2012/11
N2 - 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 D 3 50,000 IU monthly for three doses was safe. Increases in 25-OHD occurred in treated participants regardless of antiretroviral regimen.
AB - 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 D 3 50,000 IU monthly for three doses was safe. Increases in 25-OHD occurred in treated participants regardless of antiretroviral regimen.
UR - http://www.scopus.com/inward/record.url?scp=84868623121&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84868623121&partnerID=8YFLogxK
U2 - 10.1210/jc.2012-2600
DO - 10.1210/jc.2012-2600
M3 - Article
C2 - 22933542
AN - SCOPUS:84868623121
VL - 97
SP - 4004
EP - 4013
JO - Journal of Clinical Endocrinology and Metabolism
JF - Journal of Clinical Endocrinology and Metabolism
SN - 0021-972X
IS - 11
ER -