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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 March 2013 by Semmelweis University
Sponsor:
Information provided by (Responsible Party):
Istvan Takacs, Semmelweis University
ClinicalTrials.gov Identifier:
NCT01518959
First received: January 6, 2012
Last updated: March 20, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Lymphoid Leukemia
 Drug: Cholecalciferol
Drug: oleum neutralicum
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III, Controlled, Double-blind, Randomized Study of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Semmelweis University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Time to treatment needed [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2012
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
no treatment
 Drug: oleum neutralicum
9 ml monthly
Active Comparator: 25-OH-Vitamin-D3
treatment
 Drug: Cholecalciferol
180.000 IU monthly

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01518959

Contacts
Contact: Istvan Takacs, M.D., Ph.D. +36-1-210-0278 ext 51500 takist@bel1.sote.hu

Locations
Hungary
Semmelweis University - 1st Departement of Internal Medicine Recruiting
Budapest, Hungary, 1083
Contact: Istvan Takacs, MD, PhD     +36-1-210-0278 ext 51500     takist@bel1.sote.hu    
Principal Investigator: Istvan Takacs, MD, PhD            
Sponsors and Collaborators
Semmelweis University
Investigators
Principal Investigator: Istvan Takacs, MD, PhD Semmelweis University
  More Information

No publications provided

Responsible Party: Istvan Takacs, Clinical Professor, Semmelweis University
ClinicalTrials.gov Identifier: NCT01518959     History of Changes
Other Study ID Numbers: D-HEM
Study First Received: January 6, 2012
Last Updated: March 20, 2013
Health Authority: Hungary: Institutional Ethics Committee

Additional relevant MeSH terms:
Hematologic Diseases
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 23, 2013