NCT01518959

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

Phase III, Controlled, Double-blind, Randomized Study of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Semmelweis University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Cholecalciferol	180.000 IU monthly
DRUG	oleum neutralicum	Placebo comparator, 9 ml monthly

Timeline

• Start date: 2012-01-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2012-01-26
• Last updated: 2020-07-16

Locations

1 site across 1 country: Hungary