Clinical trials to investigate the effect of vitamin D supplementation on serum levels of heat shock protein 60 in patients with coronary heart disease
One of the most common cardiovascular disease is atherosclerosis that begins with inflammation of the artery walls and cause endothelial dysfunction, plaque vulnerability and rupture, and atherosclerotic plaque rupture that leading to partial or complete blockage of the coronary arteries is the most common cause of Coronary Heart Disease. Recent studies have shown that atherosclerotic lesions topically in the form of a family of proteins called heat shock proteins and specifically the family of heat shock 60-accumulate, causing penetrate T cells to the vascular wall and thus stimulate the secretion of inflammatory factors. On the other hand relation between Vitamin D deficiency and risk of cardiovascular disease with increased inflammatory markers have shown. So the present study is a double blind clinical trial to investigate the effect of vitamin D supplementation on serum levels of heat shock protein 60 in patients with coronary heart disease was developed. 80 people, ages 30 to 60 years, in accordance with the conditions of the study will be recruited from Rasool Akram Hospital. Informed consent form will be completed by each participant at the beginning of study. The participants were randomly divided into two groups: receiving either 50000 IU vitamin D or placebo for 8 week. At the beginning and end of the study, heat shock protein 60, vitamin D, inflammatory markers, Pro oxidant antioxidant balance, lipid profile will measure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201612122365N14
Registration date:2017-01-10, 1395/10/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-10, 1395/10/21
Registrant information
Name
Mohammad Reza Vafa
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4734
Email address
vafa.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
School of Public Health, Iran University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trials to investigate the effect of vitamin D supplementation on serum levels of heat shock protein 60 in patients with coronary heart disease
Public title
The effect of vitamin D supplement on treatment and prevention of Coronary Heart Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 30 to 60 years; women and men with coronary heart disease ; Willingness to participate in research
exclusion criteria: BMI >35 kg / m2; Vitamin D levels higher than 30 ng / ml; Disease (cancer, myocardial infarction, diabetes, liver problems and kidney); Drugs using out of treatment protocol; Using oral and injectable nutritional supplements for at least the last 4 months (vitamins D, C, E, calcium, magnesium, potassium and multivitamins, omega-3); Using any herbal remedies; Consumption any foods fortified with vitamin D; pregnancy and lactation; Smoking; Alcohol consumption
withdraw criteria: Consume less than 7 tablets of 8 tablet at the end of the study ; The occurrence of any event that may affect the health; Any acute illness during the study; Unwillingness to continue cooperation in research
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Iran University of Medical Science
Street address
Iran University of Medical Science, Hemat highway, Tehran, Iran
City
Tehran
Postal code
1449614535
Approval date
2016-08-10, 1395/05/20
Ethics committee reference number
IR.IUMS.REC 1395.95-02-27-9411323003
Health conditions studied
1
Description of health condition studied
Coronary Heart Disease
ICD-10 code
I25.0
ICD-10 code description
Atherosclerotic cardiovascular disease, so described
Primary outcomes
1
Description
Heat Shock Protein 60
Timepoint
before and 2 month after intervention
Method of measurement
ng/ml by ELISA
Secondary outcomes
1
Description
Physical Activity
Timepoint
Before and two months after intervention
Method of measurement
According to MET-minutes / week by 7 days questionnaire of physical activity
2
Description
Level of physical activity
Timepoint
Before and two months after intervention
Method of measurement
According to three conditions: light, medium and intense physical activity by 7 days questionnaire
3
Description
sun exposure
Timepoint
Before and two months after intervention
Method of measurement
According to time (minutes) per day using 24 hour recall questionnaire
4
Description
Dietary calcium intake
Timepoint
Before and two months after intervention
Method of measurement
mg/day by 24 hour recall questionnaire
5
Description
dietary vitamin d intake
Timepoint
Before and two months after intervention
Method of measurement
unit/day by 24 hour recall questionnaire
6
Description
prothrombin hormone (PTH)
Timepoint
Before and two months after intervention
Method of measurement
pg/ml by ELISA
7
Description
energy intake
Timepoint
Before and two months after intervention
Method of measurement
kcal/day by 24 hour recall questionnaire
8
Description
Muscle mass and body fat percentage
Timepoint
Before and two months after intervention
Method of measurement
percentage by Beurer devices
9
Description
waist circumference
Timepoint
Before and two months after intervention
Method of measurement
cm by metre
10
Description
25(OH)D3
Timepoint
Before and two months after intervention
Method of measurement
nmol/l by ELISA
11
Description
Body mass index
Timepoint
Before and two months after intervention
Method of measurement
kg/m2 by Calculate the ratio of the weight by the square of height
12
Description
blood pressure
Timepoint
Before and two months after intervention
Method of measurement
mmHg by Mercury manometers
13
Description
Triglyceride
Timepoint
Before and two months after intervention
Method of measurement
mg/dl by Biochemical auto analyzer
14
Description
Total cholesterol
Timepoint
Before and two months after intervention
Method of measurement
mg/dl by Biochemical auto analyzer
15
Description
High Density Lipoprotein (HDL)
Timepoint
Before and two months after intervention
Method of measurement
mg/dl by Biochemical auto analyzer
16
Description
Pro-oxidant- antioxidant balance
Timepoint
Before and two months after intervention
Method of measurement
HK-unit by Photometric method
17
Description
Low Density Lipoprotein (LDL)
Timepoint
Before and two months after intervention
Method of measurement
mg/dl by Biochemical auto analyzer
18
Description
Tumor Necrosis Factor-α (TNF-α)
Timepoint
Before and two months after intervention
Method of measurement
pg/ml by ELISA
19
Description
Interleukin-17 (IL-17)
Timepoint
Before and two months after intervention
Method of measurement
pg/ml by ELISA
20
Description
weight
Timepoint
Before and two months after intervention
Method of measurement
kg by Digital scale
Intervention groups
1
Description
vitamin d supplement, 50000 IU, 1 time per week for 8 weeks
Category
Treatment - Drugs
2
Description
placebo, 50000 IU, 1 time per week for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool-e-Akram hospital
Full name of responsible person
seyed hashem sezavar
Street address
Hazrat-e Rasool General Hospital, Niyayesh St., Satarkhan St., Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
mohammadreza vafa
Street address
Iran University of Medical Science, beside milad hospital, shahid hemat high way, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Science
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
Iran university of medical science
Full name of responsible person
mohammadreza vafa
Position
professor
Other areas of specialty/work
Street address
nutrition department, health faculty, Iran university of medical science, beside milad tower, shahid hemat highway, Tehran, iran
City
tehran
Postal code
1449614535
Phone
+98 21 8670 4743
Fax
Email
rezavafa@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran university of medical science
Full name of responsible person
mohammadreza vafa
Position
PhD
Other areas of specialty/work
Street address
nutrition department, health faculty, Iran university of medical science, beside milad tower, shahidhemathighway, tehran
City
tehran
Postal code
Phone
+98 21 8670 4743
Fax
Email
rezavafa@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
iran university of medical science
Full name of responsible person
mohammadreza vafa
Position
PHD
Other areas of specialty/work
Street address
nutrition department, health faculty, Iran university of medical science, beside milad tower, shahid hemat highway, Tehran, Iran
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)