Determine the effect of vitamin D on left ventricular ejection fraction in patients with chronic heart failure
Design
This clinical trial study is double blinded and parallel. Patients with chronic heart failure are divided into two groups receiving vitamin D as the intervention group and placebo recipient as placebo group and are evaluated for ejection fraction before and after receiving vitamin D and placebo.
Settings and conduct
Patients referring to Ayatollah Mousavi Hospital in Zanjan who have been diagnosed with systolic heart failure, have been evaluated the left ventricular ejection fraction and cardiac failure score by using vivid echocardiography and biplane simpson prior before taking the drug. The variables studied are evaluated after 8 weeks of intervention.
Participants/Inclusion and exclusion criteria
Inclusion from study:
Patients with chronic heart failure with a ejection fraction of less than 45% and greater than 20% (based on Framingham criteria, NYAH Class I, II, III)
, Vitamin D levels less than 30 ng / dl, over age 40
Exclusion from study:
Patients with Hypercalcemia, Osteomalacia or Corticosteroid therapy
Intervention groups
Individuals with systolic insufficiency are randomly divided into two groups of intervention group and placebo group. To a group, a placebo drug or the appearance of a capsule of vitamin D and to intervention group the natural vitamin D is given, 50,000 units and weekly for 8 weeks. Before taking the medication and 8 weeks after taking the medication, the left ventricular ejection fraction and the heart failure rating based on the NYHA ranking were calculated by vivid echocardiography with Biplane simpson method
Main outcome variables
Ejection Fraction changes, end diastolic volume, and heart failure Class
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190410043236N1
Registration date:2019-07-08, 1398/04/17
Registration timing:retrospective
Last update:2019-07-08, 1398/04/17
Update count:0
Registration date
2019-07-08, 1398/04/17
Registrant information
Name
Hamid Khederlou
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3353 4019
Email address
ham_khed@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-05-02, 1395/02/13
Expected recruitment end date
2017-04-15, 1396/01/26
Actual recruitment start date
2016-10-05, 1395/07/14
Actual recruitment end date
2018-07-17, 1397/04/26
Trial completion date
2018-11-17, 1397/08/26
Scientific title
Effect of vitamin D on improvement of left ventricular ejection fraction in patients with systolic heart failure
Public title
Effect of vitamin D on improvement of left ventricular ejection fraction in patients with systolic heart failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic heart failure with 20%≤EF≤45% (based on Framingham criteria, NYAH Class I, II, III)
The level of 25 (OH) Vit D is less than 30 ngr / dl
Age over 40 years
In present study, simple randomization method was used.
Blinding (investigator's opinion)
Double blinded
Blinding description
This double-blind study was carried out and the cardiologist who do echocardiography patients, as well as those taking medication or placebo, are blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zanjan University of Medical Sciences Ethics Committee
Street address
Azad Blv.- Headquarters of Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
6856568823
Approval date
2016-04-14, 1395/01/26
Ethics committee reference number
ZUMS.REC.1395.205
Health conditions studied
1
Description of health condition studied
Systolic Heart failure
ICD-10 code
130-152
ICD-10 code description
IX Diseases of the circulatory system
2
Description of health condition studied
Systolic Heart failure
ICD-10 code
150.1
ICD-10 code description
Left ventricular failure
Primary outcomes
1
Description
Ejection Fraction
Timepoint
Before beginning the intervention with vitamin D and placebo and then 2 months after the intervention
Method of measurement
Echocardiography
2
Description
End Diastolic Volume
Timepoint
Before beginning the intervention with vitamin D and placebo and then 2 months after the intervention
Method of measurement
Echocardiography
3
Description
Heart Failure Class
Timepoint
Before beginning the intervention with vitamin D and placebo and then 2 months after the intervention
Method of measurement
Echocardiography
Secondary outcomes
1
Description
Vitamin D
Timepoint
Before the intervention, then two months after the intervention with vitamin D and placebo
Method of measurement
High Performance Liquid Chromatography
2
Description
Albumin
Timepoint
Before the intervention, then two months after the intervention with vitamin D and placebo
Method of measurement
Immunoassay
3
Description
Creatinine
Timepoint
Before the intervention, then two months after the intervention with vitamin D and placebo
Method of measurement
Immunoassay
4
Description
Calcium
Timepoint
Before the intervention, then two months after the intervention with vitamin D and placebo
Method of measurement
Ion Selected (Specific) Electrode
5
Description
Phosphor
Timepoint
Before the intervention, then two months after the intervention with vitamin D and placebo
Method of measurement
Ion Selected (Specific) Electrode
Intervention groups
1
Description
Intervention group: Intervention group: A 50000 unit capsule of vitamin D, manufactured by Abidi company, is given weekly and at 50,000 units for 8 weeks. It should be noted that patients will not be aware of the type of medicine. Patients are monitored for 2 months.
Category
Treatment - Drugs
2
Description
Placebo group: Appearance of 50,000 capsules of vitamin D, manufactured by Abidi company, is given weekly for 8 weeks. It should be noted that patients will not be aware of the type of medicine. Patients are monitored for 2 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital in Zanjan
Full name of responsible person
Dr. Reza Hassanzadeh Makuei
Street address
Ayatollah Mousavi Hospital-Gawazang Road
City
Zanjan
Province
Zanjan
Postal code
2322654235
Phone
+98 24 3353 4019
Email
Mousavihospital@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Alireza Shoghli
Street address
Headquarters of Zanjan University of Medical Sciences.Azad Blv.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
80
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Reza Hassanzadeh Makuei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Ayatollah Mousavi Hospital-Gawazang Road
City
Zanjan
Province
Zanjan
Postal code
5235255225
Phone
+98 24 3353 4019
Email
makuei42@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Reza Hassanzadeh Makuei
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Ayatollah Mousavi Hospital-Gavazang Road
City
Zanjan
Province
Zanjan
Postal code
5225665855
Phone
+98 24 3353 4019
Email
makuei42@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Hamid Khederlou
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Ayatollah Mousavi Hospital-Gavazang Road
City
Zanjan
Province
Zanjan
Postal code
5288225852
Phone
+98 24 3353 4019
Email
ham_khed@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data files related to the use of medication and medication are also the main implications of sharing.
When the data will become available and for how long
The beginning of the access period was 1 year after the publication
To whom data/document is available
Data and other study documentation will be available to all individuals and academic and non-academic institutions.
Under which criteria data/document could be used
Individuals with data receiving conditions can have the data available after receiving the documented consent of Zanjan University of Medical Sciences
From where data/document is obtainable
Visit Zanjan University of Medical Sciences at your personal or e-mail address and get consent for received information.
What processes are involved for a request to access data/document
Individuals or institutions, in person or by email, with his introduction and explanation of the purpose of the visit to the Zanjan University of Medical Sciences has the opportunity to have information and can have information within about 1 month.