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

Primary Purpose

Chronic Lymphoid Leukemia

Status
Terminated
Phase
Phase 3
Locations
Hungary
Study Type
Interventional
Intervention
Cholecalciferol
oleum neutralicum
Sponsored by
Semmelweis University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphoid Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Semmelweis University - 1st Departement of Internal Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Cholecalcipherol

Arm Description

no treatment

Treatment with 180 000 IU cholecalcipherol monthly

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Time to treatment needed
Blood lymphocyte count

Full Information

First Posted
January 6, 2012
Last Updated
July 14, 2020
Sponsor
Semmelweis University
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1. Study Identification

Unique Protocol Identification Number
NCT01518959
Brief Title
The Effect of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment rate; technical issues with sample storage
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Semmelweis University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphoid Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
no treatment
Arm Title
Cholecalcipherol
Arm Type
Active Comparator
Arm Description
Treatment with 180 000 IU cholecalcipherol monthly
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Intervention Description
180.000 IU monthly
Intervention Type
Drug
Intervention Name(s)
oleum neutralicum
Intervention Description
Placebo comparator, 9 ml monthly
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
up to 5 years
Secondary Outcome Measure Information:
Title
Time to treatment needed
Time Frame
up to 5 years
Title
Blood lymphocyte count
Time Frame
monthly, up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Istvan Takacs, MD, PhD
Organizational Affiliation
Semmelweis University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Semmelweis University - 1st Departement of Internal Medicine
City
Budapest
ZIP/Postal Code
1083
Country
Hungary

12. IPD Sharing Statement

Learn more about this trial

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

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