NCT02517814

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

August 7, 2015

Status Verified

August 1, 2015

Enrollment Period

1 year

First QC Date

August 5, 2015

Last Update Submit

August 6, 2015

Conditions

Cardiomyopathy, Dilated

Outcome Measures

Primary Outcomes (1)

  • Number of participants with Improvement of heart function

    6 months

Study Arms (1)

Patients with cardiomyopathy

EXPERIMENTAL

Patients with vitamin D deficiency and cardiomyopathy will receive supplementation with vitamin D 400 units per day for 6 months.

Dietary Supplement: Vitamin D

Interventions

Vitamin DDIETARY_SUPPLEMENT
Patients with cardiomyopathy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with idiopathic cardiomyopathy

You may not qualify if:

  • Post heart surgery
  • Congenital heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Eias Kassem, MD

CONTACT

972-4-6304331eiask@hy.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2015

First Posted

August 7, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

August 7, 2015

Record last verified: 2015-08

Locations

IL(1)