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

Semmelweis University

Status and phase: Terminated; Phase 3

Conditions: Chronic Lymphoid Leukemia

Treatments: Drug: Cholecalciferol; Drug: oleum neutralicum

Study type: Interventional

Funder types: Other

Identifiers

NCT01518959

D-HEM

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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31 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

no treatment

Treatment:

Drug: oleum neutralicum

Cholecalcipherol

Active Comparator group

Description:

Treatment with 180 000 IU cholecalcipherol monthly

Treatment:

Drug: Cholecalciferol