The Prevalence of Vitamin D Deficiency and Effects of Vitamin D Supplementation in HIV-1 Infected Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00306410
First received: March 22, 2006
Last updated: February 28, 2007
Last verified: February 2007

March 22, 2006
February 28, 2007
January 2006
Not Provided
normalization of vitamin D levels at 12 weeks
Same as current
Complete list of historical versions of study NCT00306410 on ClinicalTrials.gov Archive Site
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The Prevalence of Vitamin D Deficiency and Effects of Vitamin D Supplementation in HIV-1 Infected Patients
The Prevalence of Vitamin D Deficiency and Effects of Vitamin D Supplementation in HIV-1 Infected Patients

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.

Vitamin D deficiency is common in, especially black, HIV-seropositive patients. Vitamin D deficiency can be caused by lack of sunlight and/or insufficient vitamin D intake via diet. The HIV infection itself and antiretroviral therapy (ART) may also cause vitamin D deficiency. ART interferes with cytochrome p450 activity and as such might affect vitamin D metabolism.

Vitamin D has several important physiological functions such as 1. regulation of calcium and phosphate homeostasis, 2. immunomodulatory properties and 3. effects on adipocyte differentiation. Low vitamin D levels lead to decreased bone mineralization, eventually resulting in rachitis(children) or osteomalacia (in adults). In addition vitamin D deficiency leads to secondary hyperparathyroidism, which leads to even more bone matrix demineralization. In HIV infected persons the overall prevalence of osteopenia and osteoporoses is 14-84% and 0-45% respectively. Vitamin D has been suggested to play a role in HIV-associated bone disorders. The vitamin D status also affects the host defence in HIV patients; a significantly lower CD4 cell count has been found in patients with 1,25(OH)vitamin D deficiency. Furthermore, the influence of vitamin D on adipocyte differentiation and the effect of HAART on vitamin D levels might be relevant for changes in fat distribution and the development of insulin resistance as is seen days after initiation of HAART.

Vitamin D is metabolized in the body trough cytochrome P450 enzymes. HAART might interact with vitamin D metabolism on basis of CYP3A4, which plays an important role in clearance of most antiretroviral agents and also showed to be a vitamin D 24 and 25-hydroxylase in vitro. We hypothesize that PI’s lead to lower 1a,25(OH)2D3 by suppressing 1a- and 25-hydroxylase activity.

The results of our pilot showed that 25(OH)D deficiency is common among HIV patients. Seen the diversity of functions of vitamin D, we hypothesize that it’s beneficial for the patients to have a normal vitamin D status. Therefore, supplementation of vitamin D is warranted.

In this study we want to investigate if, despite the complex interaction between HAART/ HIV and vitamin D metabolism, supplementation of colecalciferol (2000 IU daily) will lead to normalization of the vitamin D levels. Furthermore, we want to study the effects of normalization of vitamin D levels on bone mineral density, immune and adipocyte function. Therefore we will do a prospective, randomized, double-blind, placebo-controlled vitamin D intervention study in vitamin D deficient HIV1-seropositive patients.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Vitamin D Deficiency
  • HIV Infections
Drug: colecalciferol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
85
July 2007
Not Provided

Inclusion Criteria:

  • >18 jr
  • able to give informed consent
  • HIV seropositive diagnosed with standard techniques
  • Hypovitaminoses D

Exclusion Criteria:

  • Hypercalcemia: calcium levels >2.60 mmol/L
  • Renal disorders: serum creatinine >2 times Upper limit of normal (ULN) (110 mmol/l)
  • Liver disorders; elevation of ASAT or ALAT >5 x ULN. The ULNs are 40 IU/L and 45 IU/L for ASAT and ALAT, respectively.
  • Pregnancy
  • Drug or alcohol abuse
  • Non compliance
Both
18 Years and older
No
Contact: André JA van der Ven, MD, PhD +0031243618819 a.vanderven@aig.umcn.nl
Contact: Carolien JP van den Bout-van den Beukel, MSc +0031243618819 c.vandenbeukel@aig.umcn.nl
Netherlands
 
NCT00306410
VIDI trial
Not Provided
Not Provided
Radboud University
Not Provided
Principal Investigator: André JAM van der Ven, MD, PhD Radboud University
Radboud University
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP