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

Phase 3

Terminated

• Conditions: Chronic Lymphoid Leukemia
• Interventions: Drug: oleum neutralicum; Drug: Cholecalciferol

• Registration Number: NCT01518959
• Lead Sponsor: Semmelweis University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-06
• Study First Submitted QC: 2012-01-25
• Study First Posted: 2012-01-26
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-14
• Last Update Posted: 2020-07-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	oleum neutralicum	no treatment
Cholecalcipherol	Cholecalciferol	Treatment with 180 000 IU cholecalcipherol monthly

Primary Outcome Measures

Name	Time	Method
Overall survival	up to 5 years

Secondary Outcome Measures

Name	Time	Method
Time to treatment needed	up to 5 years
Blood lymphocyte count	monthly, up to 5 years

Trial Locations

Locations (1)

Semmelweis University - 1st Departement of Internal Medicine; 🇭🇺 Budapest, Hungary