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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2014 by Istvan Takacs, Semmelweis University.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Istvan Takacs, Semmelweis University
ClinicalTrials.gov Identifier:
NCT01518959
First received: January 6, 2012
Last updated: November 18, 2014
Last verified: November 2014

January 6, 2012
November 18, 2014
January 2012
January 2017   (Final data collection date for primary outcome measure)
Overall survival [ Time Frame: up to 5 years ]
  • Overall survival [ Time Frame: up to 5 years ]
  • Blood lymphocyte count [ Time Frame: monthly, up to 5 years ]
Complete list of historical versions of study NCT01518959 on ClinicalTrials.gov Archive Site
  • Time to treatment needed [ Time Frame: up to 5 years ]
  • Blood lymphocyte count [ Time Frame: monthly, up to 5 years ]
Time to treatment needed [ Time Frame: up to 5 years ]
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Lymphoid Leukemia
  • Drug: Cholecalciferol
    180.000 IU monthly
  • Drug: oleum neutralicum
    Placebo comparator, 9 ml monthly
  • Placebo Comparator: Placebo
    no treatment
    Intervention: Drug: oleum neutralicum
  • Active Comparator: Cholecalcipherol
    Treatment with 180 000 IU cholecalcipherol monthly
    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.
 
Unknown status
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Hungary
 
 
NCT01518959
D-HEM
No
Not Provided
Not Provided
Not Provided
Istvan Takacs, Semmelweis University
Semmelweis University
Not Provided
Principal Investigator: Istvan Takacs, MD, PhD Semmelweis University
Semmelweis University
November 2014

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