Phase III, Controlled, Double-blind, Randomized Study of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases
Overview
- Phase
- Phase 3
- Intervention
- oleum neutralicum
- Conditions
- Chronic Lymphoid Leukemia
- Sponsor
- Semmelweis University
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Overall survival
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
Recent data have shown that the inadequate vitamin D status plays a role in the manifestation of the haematologic tumors and serum vitamin D level has a prognostic role also as it determines the tumor mortality. But data have not proved a causal relationship between the inadequate vitamin D status and the unfavourable outcomes so far. It is also still unknown, whether the normalization of vitamin D status in patient with vitamin D inadequacy is able to improve the prognosis and survival.
In this study the investigators examine the role of the adequate vitamin D substitution in the improvement of the outcomes of haematologic disorders.
Investigators
Istvan Takacs
Clinical Professor
Semmelweis University
Eligibility Criteria
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
Arms & Interventions
Placebo
no treatment
Intervention: oleum neutralicum
Cholecalcipherol
Treatment with 180 000 IU cholecalcipherol monthly
Intervention: Cholecalciferol
Outcomes
Primary Outcomes
Overall survival
Time Frame: up to 5 years
Secondary Outcomes
- Time to treatment needed(up to 5 years)
- Blood lymphocyte count(monthly, up to 5 years)