Vitamin D DeficiencyPhase 2NCT00306410
The Prevalence of Vitamin D Deficiency and Effects of Vitamin D Supplementation in HIV-1 Infected Patients
A Phase 2 study testing colecalciferol in people with Vitamin D Deficiency and HIV Infections, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin D Deficiency, HIV Infections
- What is being tested?
- colecalciferol
- How many people
- 85 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2006to Jul 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 jr
- able to give informed consent
- HIV seropositive diagnosed with standard techniques
- Hypovitaminoses D
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Nijmegen Medical Center
Nijmegen, P.O. BOX 9101
André JAM van der Ven, MD, PhD
Carolien JP van den Bout- van den Beukel, MSc
About this study
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.
Read the 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.
- Conditions
- Vitamin D Deficiency, HIV Infections
- Being tested
- colecalciferol
- Keywords
- Vitamin D deficiency, HIV/AIDS, HAART, T-Lymphocytes, Regulatory, insulin resistance, bone density
- Medical subject headings
- Vitamin D Deficiency, HIV Infections, Acquired Immunodeficiency Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colecalciferolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
normalization of vitamin D levels at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2006 (estimated)
- Study startJan 2006
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 85 participants
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- André JAM van der Ven, MD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306410
- Sponsor's protocol ID
- VIDI trial
- Status last verified
- Feb 2007
- First submitted
- 22 Mar 2006
- Last updated
- 1 Mar 2007
- Results posted
- No
Publications
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.
PubMed 15195003Haug 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.
PubMed 9814454Cozzolino 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.
PubMed 12598771Mondy 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.
PubMed 15764959Holick 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.
PubMed 16295817
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Vitamin D Deficiency and Effects of Vitamin D Supplementation in HIV-1 Infected Patients
- ClinicalTrials.gov ID
- NCT00306410
- Acronym / sponsor ID
- VIDI trial
- Conditions
- Vitamin D Deficiency, HIV Infections
- Keywords
- Vitamin D deficiency, HIV/AIDS, HAART, T-Lymphocytes, Regulatory, insulin resistance, bone density
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Jul 2007
- First posted
- 23 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >18 jr
- able to give informed consent
- HIV seropositive diagnosed with standard techniques
- Hypovitaminoses D
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colecalciferol | Drug | – |
Primary outcome
normalization of vitamin D levels at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2007.
- Background: PubMed 15195003Madeddu 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.
- Background: PubMed 9814454Haug 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.
- Background: PubMed 12598771Cozzolino 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.
- Background: PubMed 15764959Mondy 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.
- Background: PubMed 16295817Holick 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
André JAM van der Ven, MD, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing colecalciferol in people with Vitamin D Deficiency and HIV Infections, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact André JA van der Ven, MD, PhD (+0031243618819, a.vanderven@aig.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
normalization of vitamin D levels at 12 weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00306410, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2007.