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Insufficient recruitment rate; technical issues with sample storage
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | no treatment |
|
| Cholecalcipherol | Active Comparator | Treatment with 180 000 IU cholecalcipherol monthly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Drug | 180.000 IU monthly |
| |
| oleum neutralicum |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to treatment needed | up to 5 years | |
| Blood lymphocyte count | monthly, up to 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Istvan Takacs, MD, PhD | Semmelweis University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis University - 1st Departement of Internal Medicine | Budapest | 1083 | Hungary |
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| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Drug |
Placebo comparator, 9 ml monthly |
|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |