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

NCT01518959 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2020-07-16

No results posted yet for this study

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.

Conditions

  • Chronic Lymphoid Leukemia

Interventions

DRUG

Cholecalciferol

180.000 IU monthly

DRUG

oleum neutralicum

Placebo comparator, 9 ml monthly

Sponsors & Collaborators

  • Semmelweis University

    lead OTHER

Principal Investigators

  • Istvan Takacs, MD, PhD · Semmelweis University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01518959 on ClinicalTrials.gov