Serum 25-hydroxyvitamin D response to vitamin D3 supplementation 50,000 IU monthly in youth with HIV-1 infection

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, [No Value] 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

Research output: Contribution to journalArticle

36 Citations (Scopus)

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 languageEnglish (US)
Pages (from-to)4004-4013
Number of pages10
JournalJournal of Clinical Endocrinology and Metabolism
Volume97
Issue number11
DOIs
StatePublished - Nov 2012
Externally publishedYes

Fingerprint

Cholecalciferol
efavirenz
Vitamin D
HIV Infections
HIV-1
Serum
Placebos
Vitamin D Deficiency
Therapeutics
Viral Load
African Americans
Multicenter Studies
25-hydroxyvitamin D
Toxicity
HIV
Safety
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Biochemistry
  • Clinical Biochemistry
  • Endocrinology
  • Biochemistry, medical
  • Endocrinology, Diabetes and Metabolism

Cite this

Havens, P. L., Mulligan, K., Hazra, R., Flynn, P., Rutledge, B., Van Loan, M. D., ... Flanagan, N. V. (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), 4004-4013. https://doi.org/10.1210/jc.2012-2600

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 journalArticle

Havens, PL, Mulligan, K, Hazra, R, Flynn, P, Rutledge, B, Van Loan, MD, Lujan-Zilbermann, J, Kapogiannis, BG, Wilson, CM, Stephensen, CB, Emmanuel, NV, Lujan-Zilberman, NV, Julian, NV, Belzer, NV, Flores, NV, Tucker, NV, Kovacs, NV, Homans, NV, Lozano, NV, D'Angelo, NV, Hagler, NV, Trexler, NV, Douglas, NV, Tanney, NV, DiBenedetto, NV, Martinez, NV, Bojan, NV, Jackson, NV, Febo, NV, Ayala-Flores, NV, Fuentes-Gomez, NV, Futterman, NV, Enriquez-Bruce, NV, Campos, NV, Steever, NV, Geiger, NV, Moscicki, NV, Auerswald, NV, Irish, NV, Abdalian, NV, Kozina, NV, Baker, NV, Peralta, NV, Gorle, NV, Friedman, NV, Maturo, NV, Major-Wilson, NV, Puga, NV, Leonard, NV, Inman, NV, Flynn, NV, Dillard, NV, Garofalo, NV, Brennan, NV & Flanagan, NV 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, vol. 97, no. 11, pp. 4004-4013. https://doi.org/10.1210/jc.2012-2600
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]. / Serum 25-hydroxyvitamin D response to vitamin D3 supplementation 50,000 IU monthly in youth with HIV-1 infection. In: Journal of Clinical Endocrinology and Metabolism. 2012 ; Vol. 97, No. 11. pp. 4004-4013.
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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.",
author = "Havens, {Peter L.} and Kathleen Mulligan and Rohan Hazra and Patricia Flynn and Brandy Rutledge and {Van Loan}, {Marta D.} and Jorge Lujan-Zilbermann and Kapogiannis, {Bill G.} and Wilson, {Craig M.} and Stephensen, {Charles B.} and Emmanuel, {[No Value]} and Lujan-Zilberman, {[No Value]} and Julian, {[No Value]} and Belzer, {[No Value]} and Flores, {[No Value]} and Tucker, {[No Value]} and Kovacs, {[No Value]} and Homans, {[No Value]} and Lozano, {[No Value]} and D'Angelo, {[No Value]} and Hagler, {[No Value]} and Trexler, {[No Value]} and Douglas, {[No Value]} and Tanney, {[No Value]} and DiBenedetto, {[No Value]} and Martinez, {[No Value]} and Bojan, {[No Value]} and Jackson, {[No Value]} and Febo, {[No Value]} and Ayala-Flores, {[No Value]} and Fuentes-Gomez, {[No Value]} and Futterman, {[No Value]} and Enriquez-Bruce, {[No Value]} and Campos, {[No Value]} and Steever, {[No Value]} and Geiger, {[No Value]} and Moscicki, {[No Value]} and Auerswald, {[No Value]} and Irish, {[No Value]} and Abdalian, {[No Value]} and Kozina, {[No Value]} and Baker, {[No Value]} and Peralta, {[No Value]} and Gorle, {[No Value]} and Friedman, {[No Value]} and Maturo, {[No Value]} and Major-Wilson, {[No Value]} and Puga, {[No Value]} and Leonard, {[No Value]} and Inman, {[No Value]} and Flynn, {[No Value]} and Dillard, {[No Value]} and Garofalo, {[No Value]} and Brennan, {[No Value]} and Flanagan, {[No Value]}",
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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.

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