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: 8.1 Level: LLT Classification code 10020180 Term: HIV positive
Conditions
Interventions
Trade Name: rocaltrol
Pharmaceutical Form: Tablet
INN or Proposed INN: CALCITRIOL
CAS Number: 32222063
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: -1
Pharmaceut
Sponsors
Calcium and Bone Metabolic Unit Copenhange University Hospital Hvidovre
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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 Bone metabolism: serum-ICTP, -PINP, -osteocalcin, -RANKL, OPG Number of naive and mature CD4+ lymphocytes and HIV RNA | — |
Countries
Denmark
Outcome results
None listed