The effect of vitamin D3 supplementation on serum levels of B type natriuretic peptide , tumor necrosis factor alpha , high sensitivity c-reactive protein and 6 minute walk distance test in stage ш systolic heart failure patients with vitamin D deficiency
This study will be performed within 2 months to investigate the effect of vitamin D3 supplementation on serum levels of B type natriuretic peptide, tumor necrosis factor alpha, high sensitivity C- reactive protein and 6 minute walk distance test in patients with stage III systolic heart failure with vitamin D deficiency. This study is a controlled, randomized, double-blinded clinical trial and Block Randomization will be used. The study population includes men and women with heart failure and vitamin D deficiency referred to Urmia Taleghani hospital. Subjects with stage III of NYHA, vitamin D deficiency and ejection fraction less than 50% will be studied. 44 patients of them will randomly divide into intervention and placebo groups. The intervention group will receive vitamin D3 supplement tablets and the placebo group will receive size-color matched placebo tablets. Brain natriuretic peptide, tumor necrosis factor alpha, High sensitivity C-reactive protein and vitamin D levels will be measured through blood sampling before and after the intervention and will be analyzed. Also 6 minute walk distance test will be checked in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016102113678N13
Registration date:2017-03-02, 1395/12/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-02, 1395/12/12
Registrant information
Name
Saeed Ghavamzadeh
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1278 0803
Email address
ghavamzadeh_s@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Urmia University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D3 supplementation on serum levels of B type natriuretic peptide , tumor necrosis factor alpha , high sensitivity c-reactive protein and 6 minute walk distance test in stage ш systolic heart failure patients with vitamin D deficiency
Public title
The effect of vitamin D in the treatment of heart failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : class 3 of the New York Heart Association Classification(NYHA); ejection fraction less than 50% ; treated with heart failure medications in the last 3 months ; the level of vitamin D less than 20 ng/ml.
Exclusion criteria : vitamin D reception in the last 2 months ; acute gastrointestinal problems ;using interacting drugs with the homeostasis of vitamin D such as Corticosteroids , Thyroxine , anti-epileptic drugs, Tetracycline, Ketoconazole, Cholestyramine, Phenobarbital and Phenytoin ; bone fractures ; continuous consumption of cigarettes; kidney disease ; malignancies ; need to change the type and amount of drugs during the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Orjhans Street, Resalat Blvd, Urmia , Iran
City
Urmia
Postal code
5714783734
Approval date
2016-07-31, 1395/05/10
Ethics committee reference number
IRUMSU.REC.1395
Health conditions studied
1
Description of health condition studied
heart failure
ICD-10 code
I50.9
ICD-10 code description
Cardiac, heart or myocardial failure NOS
Primary outcomes
1
Description
B type natriuretic peptide
Timepoint
before and after intervention
Method of measurement
ELISA
2
Description
high sensitivity C-reactive protein
Timepoint
before and after intervention
Method of measurement
ELISA
3
Description
tumor necrosis factor alpha
Timepoint
before and after intervention
Method of measurement
ELISA
4
Description
vitamin D
Timepoint
before and after intervention
Method of measurement
ELISA
5
Description
6 minute walk distance test
Timepoint
before and after intervention
Method of measurement
walking distance (meter)
Secondary outcomes
1
Description
systolic blood pressure
Timepoint
before and after intervention
Method of measurement
manometer
2
Description
diastolic blood pressure
Timepoint
before and after intervention
Method of measurement
manometer
3
Description
weight
Timepoint
before and after intervention
Method of measurement
scale
4
Description
body mass index
Timepoint
before and after intervention
Method of measurement
with BMI formula
Intervention groups
1
Description
Viatmin D3 tablet (50000 International Unit) once a week , for two months
Category
Treatment - Drugs
2
Description
placebo tablet , once a week , for two months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Fahimeh Hosseinzade
Street address
West Azarbaijan,Urmia,Kashani st,Taleghani hospital
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Urmia University of Medical Sciences
Full name of responsible person
Dr Iraj Mohebbi
Street address
Orjhans Street, Resalat Blvd, Urmia , Iran
City
Urmia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Urmia 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
urmia medical science university
Full name of responsible person
Dr Saied Ghavamzadeh
Position
Associate Professor/Nutritional Sciences PhD
Other areas of specialty/work
Street address
Pardis Nazlou, 11 km of Nazlou Road,Urmia,Iran
City
Urmia
Postal code
Phone
+98 44 3278 0803
Fax
Email
ghavamzadeh_s@umsu.ac.irghavamzadeh@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Dr saied ghavamzadeh
Position
Associate Professor/Nutritional Sciences PhD
Other areas of specialty/work
Street address
Urmia University of Medical Sciences,Nazlu Pardis, Urmia
City
Urmia
Postal code
Phone
+98 44 3278 0803
Fax
+98 44 1278 0801
Email
ghavamzadeh_s@umsu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)