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

This study is currently recruiting participants.
Verified February 2014 by Semmelweis University
Sponsor:
Information provided by (Responsible Party):
Istvan Takacs, Semmelweis University
ClinicalTrials.gov Identifier:
NCT01518959
First received: January 6, 2012
Last updated: February 18, 2014
Last verified: February 2014

January 6, 2012
February 18, 2014
January 2012
January 2017   (final data collection date for primary outcome measure)
  • Overall survival [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Blood lymphocyte count [ Time Frame: monthly, up to 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01518959 on ClinicalTrials.gov Archive Site
Time to treatment needed [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effect of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases
Phase III, Controlled, Double-blind, Randomized Study of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Lymphoid Leukemia
  • Drug: Cholecalciferol
    180.000 IU monthly
  • Drug: oleum neutralicum
    9 ml monthly
  • Placebo Comparator: Placebo
    no treatment
    Intervention: Drug: oleum neutralicum
  • Active Comparator: 25-OH-Vitamin-D3
    treatment
    Intervention: Drug: Cholecalciferol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Not Provided
January 2017   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Istvan Takacs, M.D., Ph.D. +36-1-210-0278 ext 51500 takist@bel1.sote.hu
Hungary
 
NCT01518959
D-HEM
No
Istvan Takacs, Semmelweis University
Semmelweis University
Not Provided
Principal Investigator: Istvan Takacs, MD, PhD Semmelweis University
Semmelweis University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP