Back to resultsVitamin D Supplementation Can Improve Heart Function in Idiopathic Cardiomyopathy
Primary Purpose
Cardiomyopathy, Dilated
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
About this trial
This is an interventional diagnostic trial for Cardiomyopathy, Dilated
Eligibility Criteria
Inclusion Criteria:
- Patients with idiopathic cardiomyopathy
Exclusion Criteria:
- Post heart surgery
- Congenital heart disease
Sites / Locations
- Hillel Yaffe Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with cardiomyopathy
Arm Description
Patients with vitamin D deficiency and cardiomyopathy will receive supplementation with vitamin D 400 units per day for 6 months.
Outcomes
Primary Outcome Measures
Number of participants with Improvement of heart function
Secondary Outcome Measures
Full Information
NCT ID
NCT02517814
First Posted
August 5, 2015
Last Updated
August 6, 2015
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02517814
Brief Title
Vitamin D Supplementation Can Improve Heart Function in Idiopathic Cardiomyopathy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Vitamin D deficiency could be a high risk for cardiovascular diseases. It has been recently reported that vitamin D deficiency is another cause of heart failure and cardiomyopathies. It was found that vitamin D supplementation improved the heart function. The purpose of this study is to evaluate patients with idiopathic cardiomyopathies and determine whether vitamin D supplementation in cases where there is a deficiency, improves heart functioning.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiomyopathy, Dilated
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with cardiomyopathy
Arm Type
Experimental
Arm Description
Patients with vitamin D deficiency and cardiomyopathy will receive supplementation with vitamin D 400 units per day for 6 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Primary Outcome Measure Information:
Title
Number of participants with Improvement of heart function
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with idiopathic cardiomyopathy
Exclusion Criteria:
Post heart surgery
Congenital heart disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eias Kassem, MD
Phone
972-4-6304331
Email
eiask@hy.health.gov.il
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Vitamin D Supplementation Can Improve Heart Function in Idiopathic Cardiomyopathy
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