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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. Identifier: NCT01518959
Recruitment Status : Terminated (Insufficient recruitment rate; technical issues with sample storage)
First Posted : January 26, 2012
Last Update Posted : July 16, 2020
Information provided by (Responsible Party):
Istvan Takacs, Semmelweis University

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.

Condition or disease Intervention/treatment Phase
Chronic Lymphoid Leukemia Drug: Cholecalciferol Drug: oleum neutralicum Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2012
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
no treatment
Drug: oleum neutralicum
Placebo comparator, 9 ml monthly

Active Comparator: Cholecalcipherol
Treatment with 180 000 IU cholecalcipherol monthly
Drug: Cholecalciferol
180.000 IU monthly

Primary Outcome Measures :
  1. Overall survival [ Time Frame: up to 5 years ]

Secondary Outcome Measures :
  1. Time to treatment needed [ Time Frame: up to 5 years ]
  2. Blood lymphocyte count [ Time Frame: monthly, up to 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01518959

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Semmelweis University - 1st Departement of Internal Medicine
Budapest, Hungary, 1083
Sponsors and Collaborators
Semmelweis University
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Principal Investigator: Istvan Takacs, MD, PhD Semmelweis University
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Responsible Party: Istvan Takacs, Clinical Professor, Semmelweis University Identifier: NCT01518959    
Other Study ID Numbers: D-HEM
First Posted: January 26, 2012    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Hematologic Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Growth Substances
Bone Density Conservation Agents