Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient recruitment rate; technical issues with sample storage
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphoid Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cholecalciferol | Drug | — | UNRESOLVED |
| oleum neutralicum | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- no treatment
- interventionNames
- Drug: oleum neutralicum
- type
- ACTIVE_COMPARATOR
- label
- Cholecalcipherol
- description
- Treatment with 180 000 IU cholecalcipherol monthly
- interventionNames
- Drug: Cholecalciferol
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- up to 5 years
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available