Vitamin D status hos patienter med HIV infektion - Intervention with vitamin D - a pilot study - HIVD
Phase 1
- Conditions
- It has been shown in our clinic that many patients with HIV infektion have vitamin D deficiency and it is the aim to investigate the benefits of correcting this vitamin D deficiency on bone metabolism and immunological status.MedDRA version: 8.1Level: LLTClassification code 10020180Term: HIV positive
- Registration Number
- EUCTR2006-005039-40-DK
- Lead Sponsor
- Calcium and Bone Metabolic Unit Copenhange University Hospital Hvidovre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
a) 30 Patients with HIV infection drug-naive to HAART
b) 30 Patients with HIV infectin non-drug-naive to HAART.
Women and men,
Age > 18 years,
regardless of vitamin D status and CDC category.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Known bone-metabolic disease,
TB or sarcoidosis,
pregnant or lactating women,
patients with dementia or equal mental impairment
Terminally ill patients
Patients with active cancer with bone-metastasis
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effect of intervention with vitamin D on bone-status, calcium metabolism, immune system function and life quality in patients with HIV infection.<br>;Secondary Objective: Furthermore to investigate the vitamin D status of these patients and in case of prevalent vitamin D deficiency the reason for the vitamin D deficiency.;Primary end point(s): Vitamin D status: serum-25-OHD, 1,25-OH2D<br>Bone metabolism: serum-ICTP, -PINP, -osteocalcin, -RANKL, OPG<br>Number of naive and mature CD4+ lymphocytes and HIV RNA<br>
- Secondary Outcome Measures
Name Time Method