Trial Information
Phase III, Controlled, Double-blind, Randomized Study of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases
Inclusion Criteria:
- at least 18 years old male or female
- chronic lymphoid leukaemia, any Rai stage
- 25-OH-Vitamin-D3 level between 10 and 30 ng/mL
Exclusion Criteria:
- serum calcium > 2,60 mmol/l
- 24 hour calcium urine excretion > 0,1 mmol/kg/day
- serum phosphate > 1,45 mmol/l
- eGFR < 30 ml/min/1,73m2
- nephrolithiasis
- receiving parenteral vitamin-D3 in past 6 months
- activated vitamin-D3 treatment
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Overall survival
Outcome Time Frame:
up to 5 years
Safety Issue:
No
Principal Investigator
Istvan Takacs, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Semmelweis University
Authority:
Hungary: Institutional Ethics Committee
Study ID:
D-HEM
NCT ID:
NCT01518959
Start Date:
January 2012
Completion Date:
Related Keywords:
- Chronic Lymphoid Leukemia
- Hematologic Diseases
- Leukemia
- Leukemia, Lymphocytic, Chronic, B-Cell
- Leukemia, Lymphoid