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

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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: 50
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: February 18, 2014
Health Authority: Hungary: Institutional Ethics Committee

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

ClinicalTrials.gov processed this record on October 16, 2014