Protocol summary

Summary
We enroll 60 patients with stable congestive heart failure (CHF) based on the following criteria: Inclusion Criteria: 1- ambulatory New York Heart Association (NYHA) class ≤ III, 2- LVEF ≤ 45%, 3- Stability for at least 3 months (no exacerbation, no change in medication) and exclusion Criteria: 1- Therapy with steroids or anticonvulsants and vitamin D supplements, 2- Prior history or present hypercalcemia (serum calcium≥10.5mg/dl), 3- History of renal stone, 4- Persistent atrial fibrillation (to optimize the reproducibility of our estimation of LV function). After obtaining written consent, Patients will be randomly divided in 2 groups of interventions and controls, and then will be asked to take visually identical capsules per week of either placebo or vitamin D. Intervention group will receive 50000 IU vitamin D per week for 6 months, and controls will receive exactly similar placebo (cellulose) capsules regarding shape, size and taste as cases. Treatment will be conducted for a period of 6 months. Both groups will receive a daily supplement of 500 mg oral calcium. At the base line visit and at the end of study we will perform transthoracic echocardiography to evaluate LVEF and blood sample of each subject will be taken for Ca++, p, Alb, 25(OH) D, Cr. Patients will be reviewed every month. NYHA status at the end of the study will be evaluated again.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138706121181N1
Registration date: 2011-10-05, 1390/07/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-10-05, 1390/07/13
Registrant information
Name
Mansour Siavash
Name of organization / entity
Isfahan Endocrine and Metabolism Research Center
Country
Iran (Islamic Republic of)
Phone
+98 31 1222 0998
Email address
siavash@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2007-10-01, 1386/07/09
Expected recruitment end date
2008-09-30, 1387/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of vitamin D on left ventricular function and function class of patients with heart failure
Public title
Evaluation of the effects of vitamin D on left ventricular function and function class of patients with heart failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: ambulatory New York Heart Association (NYHA) Functional Class ≤ III; LV ejection fraction (LVEF) ≤ 45%. Exclusion: hypercalcemia; nephrolithiasis; intake of supplements containing vitamin D or calcium; therapy with corticosteroids or anticonvulsants; serum creatinine concentration > 2mg/dl.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2006-03-21, 1385/01/01
Ethics committee reference number
387019

Health conditions studied

1

Description of health condition studied
Heart Failure
ICD-10 code
I50
ICD-10 code description
Heart failure

Primary outcomes

1

Description
Left ventricular ejection fraction (LVEF)
Timepoint
six months
Method of measurement
Echocardiography

2

Description
changes in Left ventricular ejection fraction
Timepoint
6 months
Method of measurement
echocardiography

Secondary outcomes

1

Description
NYHA function class
Timepoint
six months
Method of measurement
clinical interview

Intervention groups

1

Description
Intervention group will receive 50000 IU vitamin D per week for 6 months.
Category
Treatment - Drugs

2

Description
Control group will receive exactly similar placebo (cellulose) capsules regarding shape, size and taste.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Chamran Hospital
Full name of responsible person
Maryam Kerdegari
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of medical sciences
Full name of responsible person
Peyman Adibi
Street address
Deputy of research, Isfahan University of medical sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash
Position
Associate Professor of endocrinology
Other areas of specialty/work
Street address
Khorshid Hospital
City
Isfahan
Postal code
Phone
+98 31 1222 0998
Fax
Email
siavash@med.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of medical sciences, Isfahan Cardiovascular Research center
Full name of responsible person
Mohammad Garakyaraghi
Position
Associate professor of cardiology
Other areas of specialty/work
Street address
Sedigheh Tahereh Medical Research Complex, Khorram Street
City
Isfahan
Postal code
Phone
+98 31 1337 7883
Fax
Email
garakyaraghi@med.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of medical sciences
Full name of responsible person
Mansour Siavash
Position
Associate Professor of endocrinology
Other areas of specialty/work
Street address
Khorshid Hospital, Ostandary street
City
Isfahan
Postal code
Phone
+98 31 1222 0998
Fax
Email
siavash@med.mui.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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