The Effect of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases
NCT ID: NCT01518959
Last Updated: 2020-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
31 participants
INTERVENTIONAL
2012-01-31
2017-01-31
Brief Summary
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In this study the investigators examine the role of the adequate vitamin D substitution in the improvement of the outcomes of haematologic disorders.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
no treatment
oleum neutralicum
Placebo comparator, 9 ml monthly
Cholecalcipherol
Treatment with 180 000 IU cholecalcipherol monthly
Cholecalciferol
180.000 IU monthly
Interventions
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Cholecalciferol
180.000 IU monthly
oleum neutralicum
Placebo comparator, 9 ml monthly
Eligibility Criteria
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Inclusion Criteria
* chronic lymphoid leukaemia, any Rai stage
* 25-OH-Vitamin-D3 level between 10 and 30 ng/mL
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Semmelweis University
OTHER
Responsible Party
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Istvan Takacs
Clinical Professor
Principal Investigators
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Istvan Takacs, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Semmelweis University
Locations
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Semmelweis University - 1st Departement of Internal Medicine
Budapest, , Hungary
Countries
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Other Identifiers
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D-HEM
Identifier Type: -
Identifier Source: org_study_id
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