Chronic Lymphoid Leukemia
Conditions
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.
Interventions
DRUGCholecalciferol
180.000 IU monthly
DRUGoleum neutralicum
Placebo comparator, 9 ml monthly
Sponsors
Semmelweis University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | up to 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Time to treatment needed | up to 5 years |
| Blood lymphocyte count | monthly, up to 5 years |
Countries
Hungary
Outcome results
None listed