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Vitamin 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
Hillel Yaffe Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiomyopathy, Dilated

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 5, 2015
Last Updated
August 6, 2015
Sponsor
Hillel Yaffe Medical Center
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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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