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
  Purpose

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 Intervention Phase
Vitamin D Deficiency
HIV Infections
Drug: colecalciferol
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Prevalence of Vitamin D Deficiency and Effects of Vitamin D Supplementation in HIV-1 Infected Patients

Resource links provided by NLM:


Further study details as provided by Radboud University:

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

Estimated Enrollment: 85
Study Start Date: January 2006
Estimated Study Completion Date: July 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00306410

Contacts
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

Locations
Netherlands
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
Investigators
Principal Investigator: André JAM van der Ven, MD, PhD Radboud University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00306410     History of Changes
Other Study ID Numbers: VIDI trial
Study First Received: March 22, 2006
Last Updated: February 28, 2007
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
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
Slow Virus Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 15, 2014