Effects of vitamin D compounds in 3 months on improving the ejection fraction of patients with heart failure
Non-randomized, non-blinded building, without a placebo-controlled, single-center, phase one trial
Inclusion criteria: Risk of heart failure (ejection fraction below 40%), infection serum vitamin D deficiency (serum levels of vitamin D below 20 ng/ml)
Exclusion criteria: Ejection fraction most of 40%; a lack of desire to cooperate; a recent intake of vitamin D, normal or high serum levels of vitamin D
The sample size n = 50
Elevation of serum vitamin D levels above 40 ng/ml in 3 months
The primary outcome: An increase in left ventricular emptying fraction
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014101619258N1
Registration date:2016-02-27, 1394/12/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-27, 1394/12/08
Registrant information
Name
akbar abdoli
Name of organization / entity
ardabil university od medical scienses
Country
Iran (Islamic Republic of)
Phone
+98 45 3373 3052
Email address
a.abdoli@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2015-08-11, 1394/05/20
Expected recruitment end date
2015-09-11, 1394/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of vitamin D compounds in 3 months on heart failure patients
Public title
Effect of vitamin D on heart failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Risk of heart failure (ejection fraction below 40%), infection serum vitamin D deficiency (serum levels of vitamin D below 20 ng/ml)
Exclusion criteria: Death of patient, a lack of regular drug Consumption
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardebil university of Medical Sciences
Street address
Ardebil University of medical sciences, University St.
City
Ardebil
Postal code
Approval date
2015-08-08, 1394/05/17
Ethics committee reference number
ir.arums.rec.1394.18
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
150
ICD-10 code description
Left ventricular failure
Primary outcomes
1
Description
left ventricle ejection fraction
Timepoint
before the intervention, 3 months after intervention
Method of measurement
echocardiography
Secondary outcomes
1
Description
serum levels of vitamin D
Timepoint
before the intervention, 3 months after intervention
Method of measurement
ng/ml by laboratory evaluation
Intervention groups
1
Description
Vitamin D supplements, taking oral tablet form to 50000 units weekly for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ardebil emam Khomeini hospital
Full name of responsible person
Street address
City
Ardebil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardebil university of Medical Sciences
Full name of responsible person
Dr Habibzadeh
Street address
Ardebil university street
City
Ardebil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardebil university of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ardebil emam Khomeini hospital
Full name of responsible person
Dr Adalat Hosseinian
Position
cardiologist
Other areas of specialty/work
Street address
Ardebil emam Khomeini hospital
City
Ardebil
Postal code
Phone
+98 914 151 8972
Fax
Email
a.hosseinian@arums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardebil university of Medical Sciences
Full name of responsible person
Dr Adalat Hosseinian
Position
Assistant Professor
Other areas of specialty/work
Street address
Emam Khomeini hospital
City
Ardebil
Postal code
Phone
+98 914 151 8972
Fax
Email
a.hosseinian@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)