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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00306410
Recruitment Status : Unknown
Verified February 2007 by Radboud University.
Recruitment status was:  Recruiting
First Posted : March 23, 2006
Last Update Posted : March 1, 2007
Information provided by:
Radboud University

Brief 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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency HIV Infections Drug: colecalciferol Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Prevalence of Vitamin D Deficiency and Effects of Vitamin D Supplementation in HIV-1 Infected Patients
Study Start Date : January 2006
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Primary Outcome Measures :
  1. normalization of vitamin D levels at 12 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00306410

Contact: André JA van der Ven, MD, PhD +0031243618819
Contact: Carolien JP van den Bout-van den Beukel, MSc +0031243618819

Radboud University Nijmegen Medical Center Recruiting
Nijmegen, Netherlands, P.O. BOX 9101
Principal Investigator: André JAM van der Ven, MD, PhD         
Sub-Investigator: Carolien JP van den Bout- van den Beukel, MSc         
Sponsors and Collaborators
Radboud University
Principal Investigator: André JAM van der Ven, MD, PhD Radboud University

Publications: Identifier: NCT00306410     History of Changes
Other Study ID Numbers: VIDI trial
First Posted: March 23, 2006    Key Record Dates
Last Update Posted: March 1, 2007
Last Verified: February 2007

Keywords provided by Radboud University:
Vitamin D deficiency
T-Lymphocytes, Regulatory
insulin resistance
bone density

Additional relevant MeSH terms:
HIV Infections
Vitamin D Deficiency
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents