NCT00306410|UnknownPhase 2
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Sponsor study identifier
interventional
85
1 country
1
Study Start
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
March 22, 2006
Actual (reported)March 23, 2006
Actual (reported)July 2007
Date type not reportedThis date has not been verified as actual or estimated.
normalization of vitamin D levels at 12 weeks
Radboud University Nijmegen Medical Center
Nijmegen, P.O. BOX 9101, Netherlands
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.
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.
André JAM van der Ven, MD, PhD
Radboud University Medical Center
First Submitted
March 22, 2006
First Posted
March 23, 2006
Study Start
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
July 2007
Date type not reported30000 IU Per Week Vitamin D Treatment in PCOS Patients
Contact the study team to confirm eligibility.
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.
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.
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.
This date has not been verified as actual or estimated.
Last Updated
March 1, 2007
Record last verified: 2007-02
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