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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphoid Leukemia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

up to 5 years

Safety Issue:

No

Principal Investigator

Istvan Takacs, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Semmelweis University

Authority:

Hungary: Institutional Ethics Committee

Study ID:

D-HEM

NCT ID:

NCT01518959

Start Date:

January 2012

Completion Date:

Related Keywords:

  • Chronic Lymphoid Leukemia
  • Hematologic Diseases
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

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