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

• Sponsor: Semmelweis University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01518959
• Collaborator: (none)
• Enrollment: 31
• Location: 1
• Arms: 2
• Duration (Months): 60
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphoid Leukemia	Drug: Cholecalciferol; Drug: oleum neutralicum	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase III, Controlled, Double-blind, Randomized Study of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Jan 1, 2017
• Actual Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo no treatment	Drug: oleum neutralicum; Placebo comparator, 9 ml monthly
Active Comparator: Cholecalcipherol Treatment with 180 000 IU cholecalcipherol monthly	Drug: Cholecalciferol; 180.000 IU monthly

Outcome Measures

Primary Outcome Measures

1. Overall survival [up to 5 years]

Secondary Outcome Measures

1. Time to treatment needed [up to 5 years]

2. Blood lymphocyte count [monthly, up to 5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Semmelweis University - 1st Departement of Internal Medicine	Budapest		Hungary	1083

Sponsors and Collaborators

• Semmelweis University

Investigators

• Principal Investigator: Istvan Takacs, MD, PhD, Semmelweis University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Istvan Takacs, Clinical Professor, Semmelweis University
• ClinicalTrials.gov Identifier: NCT01518959
• Other Study ID Numbers: D-HEM
• First Posted: Jan 26, 2012
• Last Update Posted: Jul 16, 2020
• Last Verified: Jul 1, 2020

• Additional relevant MeSH terms: Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Hematologic Diseases; Cholecalciferol; Vitamin D

Study Results

No Results Posted as of Jul 16, 2020