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. |
ClinicalTrials.gov 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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Vitamin D Deficiency HIV Infections | Drug: colecalciferol | Phase 2 |
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 |

- normalization of vitamin D levels at 12 weeks

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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

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 ClinicalTrials.gov identifier (NCT number): NCT00306410
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 | |
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 |
Principal Investigator: | André JAM van der Ven, MD, PhD | Radboud University |
Publications:
ClinicalTrials.gov 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 HIV/AIDS HAART |
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 Avitaminosis |
Deficiency Diseases Malnutrition Nutrition Disorders Vitamins Vitamin D Ergocalciferols Cholecalciferol Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |