The Effect of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases

• Status: Terminated
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Semmelweis University
• Treatments: Cholecalciferol; Vitamin D

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