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

Chronic Lymphoid Leukemia Clinical Trial

— D-HEM  

Official title:

Phase III, Controlled, Double-blind, Randomized Study of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01518959
• Other study ID #: D-HEM
• Status: Terminated
• Phase: Phase 3
• Start date: January 2012
• Est. completion date: January 2017

Study information

• Verified date: July 2020
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphoid Leukemia
• Hematologic Diseases
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Cholecalciferol
180.000 IU monthly
• oleum neutralicum
Placebo comparator, 9 ml monthly

Locations

Country	Name	City	State
Hungary	Semmelweis University - 1st Departement of Internal Medicine	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		up to 5 years
Secondary	Time to treatment needed		up to 5 years
Secondary	Blood lymphocyte count		monthly, up to 5 years