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

NCT01518959 | Terminated Phase 3

• 1 other identifier: D-HEM
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Overall survival

  up to 5 years

Secondary Outcomes (2)

• Time to treatment needed

  up to 5 years

• Blood lymphocyte count

  monthly, up to 5 years

Study Arms (2)

Placebo

PLACEBO COMPARATOR

no treatment

Drug: oleum neutralicum

Cholecalcipherol

ACTIVE COMPARATOR

Treatment with 180 000 IU cholecalcipherol monthly

Drug: Cholecalciferol

Interventions

Cholecalciferol DRUG

180.000 IU monthly

Cholecalcipherol

oleum neutralicum DRUG

Placebo comparator, 9 ml monthly

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 18 years old male or female
• chronic lymphoid leukaemia, any Rai stage
• OH-Vitamin-D3 level between 10 and 30 ng/mL

You may not qualify if:

• serum calcium \> 2,60 mmol/l
• 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

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University - 1st Departement of Internal Medicine

Budapest, 1083, Hungary

Location

MeSH Terms

Conditions

Leukemia, B-Cell

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Istvan Takacs, MD, PhD

  Semmelweis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 6, 2012
• First Posted: January 26, 2012
• Study Start: January 1, 2012
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: July 16, 2020

Record last verified: 2020-07

Locations

HU (1)