Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01518959
Recruitment Status : Unknown
Verified November 2014 by Istvan Takacs, Semmelweis University.
Recruitment status was:  Recruiting
First Posted : January 26, 2012
Last Update Posted : November 20, 2014
Sponsor:
Information provided by (Responsible Party):
Istvan Takacs, Semmelweis University

Tracking Information
First Submitted Date  ICMJE January 6, 2012
First Posted Date  ICMJE January 26, 2012
Last Update Posted Date November 20, 2014
Study Start Date  ICMJE January 2012
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2014)
Overall survival [ Time Frame: up to 5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 25, 2012)
  • Overall survival [ Time Frame: up to 5 years ]
  • Blood lymphocyte count [ Time Frame: monthly, up to 5 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2014)
  • Time to treatment needed [ Time Frame: up to 5 years ]
  • Blood lymphocyte count [ Time Frame: monthly, up to 5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2012)
Time to treatment needed [ Time Frame: up to 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases
Official Title  ICMJE Phase III, Controlled, Double-blind, Randomized Study of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Lymphoid Leukemia
Intervention  ICMJE
  • Drug: Cholecalciferol
    180.000 IU monthly
  • Drug: oleum neutralicum
    Placebo comparator, 9 ml monthly
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    no treatment
    Intervention: Drug: oleum neutralicum
  • Active Comparator: Cholecalcipherol
    Treatment with 180 000 IU cholecalcipherol monthly
    Intervention: Drug: Cholecalciferol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 18, 2014)
50
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2012)
300
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01518959
Other Study ID Numbers  ICMJE D-HEM
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Istvan Takacs, Semmelweis University
Study Sponsor  ICMJE Semmelweis University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Istvan Takacs, MD, PhD Semmelweis University
PRS Account Semmelweis University
Verification Date November 2014

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