Impact of 25-hydroxy vitamin D deficiency and its correction on mineral and bone disorde among hemodialysis patients - VitaDial
- Conditions
- 25-OH vitamin D deficiency and mineral - bone disorder in hemodialysis patientsMedDRA version: 9.1Level: LLTClassification code 10061292Term: Mineral metabolism disorder
- Registration Number
- EUCTR2008-002387-33-BE
- Lead Sponsor
- Hôpital Erasme
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 50
• Written informed consent
• Age 18 years or older
• End-stage renal disease on hemodialysis for at least 3 months (3 dialysis sessions or more per week)
• Serum 25-OH vitamin D levels < 30 ng/mL
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) yes
F.1.3.1 Number of subjects for this age range
• Known hypersensibility to cholecalciferol or to any constituent of the study medication (D-cure ®)
• Pregnancy or lactation period
• Woman of childbearing potential without effective contraception
• Cholecalciferol, calcitriol, paricalcitol or alfacalcidol dosage adjustment 1 month prior to enrolment
• Serum corrected calcium level > 10.2 mg/dL
• Participation in a clinical trial or receipt of investigational compound or treatment 3 months prior the enrolment
• Parathyroidectomy
• History of granulomatous disorder (sarcoidosis, tuberculosis)
• History of malignancy with a life expectancy < 12 months
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method