drugset / Trial / NCT00306410
The Prevalence of Vitamin D Deficiency and Effects of Vitamin D Supplementation in HIV-1 Infected Patients
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to determine the effect of normalization of vitamin D levels on bone density, immune and adipocyte function in HIV1-seropositive patients.
Timeline
- Start
- 2006-01
- Primary completion
- —
- Completion
- 2007-07
Publications
- Background Madeddu G, Spanu A, Solinas P, Calia GM, Lovigu C, Chessa F, Mannazzu M, Falchi A, Mura MS, Madeddu G. Bone mass loss and vitamin D metabolism impairment in HIV patients receiving highly active antiretroviral therapy. Q J Nucl Med Mol Imaging. 2004 Mar;48(1):39-48.
- Background Haug CJ, Aukrust P, Haug E, Morkrid L, Muller F, Froland SS. Severe deficiency of 1,25-dihydroxyvitamin D3 in human immunodeficiency virus infection: association with immunological hyperactivity and only minor changes in calcium homeostasis. J Clin Endocrinol Metab. 1998 Nov;83(11):3832-8. doi: 10.1210/jcem.83.11.5270.
- Background Cozzolino M, Vidal M, Arcidiacono MV, Tebas P, Yarasheski KE, Dusso AS. HIV-protease inhibitors impair vitamin D bioactivation to 1,25-dihydroxyvitamin D. AIDS. 2003 Mar 7;17(4):513-20. doi: 10.1097/00002030-200303070-00006.
- Background Mondy K, Powderly WG, Claxton SA, Yarasheski KH, Royal M, Stoneman JS, Hoffmann ME, Tebas P. Alendronate, vitamin D, and calcium for the treatment of osteopenia/osteoporosis associated with HIV infection. J Acquir Immune Defic Syndr. 2005 Apr 1;38(4):426-31. doi: 10.1097/01.qai.0000145352.04440.1e.
- Background Holick MF. Vitamin D: important for prevention of osteoporosis, cardiovascular heart disease, type 1 diabetes, autoimmune diseases, and some cancers. South Med J. 2005 Oct;98(10):1024-7. doi: 10.1097/01.SMJ.0000140865.32054.DB.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cholecalciferol | Other / unclassified | 2000 iu | — |