The study aims to determine the effect of coenzyme Q10 supplementation on blood pressure, adiponectin and inflammatory factors in the patients with hypertension on the target population of hypertensive patients referred to the Tuba health center, Sari. A total of 36 hypertensive patients will be recruited to receive Q10, oral capsules, 100 mg once daily or placebo for three months. Blood presseure, IL6, IL2, TNF-a, CRP, and adiponectin will be measured at the beginning and in the first and six and twelve weeks after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103086002N1
Registration date:2011-05-29, 1390/03/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-29, 1390/03/08
Registrant information
Name
Nasim BagheriNesami
Name of organization / entity
Shahid Sadughi University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 35 1624 0691
Email address
nbagherinesami@gmail.com
Recruitment status
Recruitment complete
Funding source
Shahid Sadughi University of Medical Sciences
Expected recruitment start date
2011-03-11, 1389/12/20
Expected recruitment end date
2011-05-15, 1390/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of coenzyme Q10 supplementation on blood pressure, inflammation factors& Adiponectin in hypertensive patients
Public title
The study of coenzyme Q10 supplementation on blood pressure, inflammation factors& Adiponectin in hypertensive patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: willingness to cooperate in the project and complete a written informed consent, diagnosis of hypertensive patients based on diagnostic criteria and clinical examination by a physician, No pregnant or breastfeeding women, the absence of any autoimmune disorders, cardio - vascular, or renal diseases, lack of nutritional supplements during the past six months
Exclusion criteria: diabetes mellitus type 1 or type 2, the history of disease such as myocardial infarction, cardiac dysfunction, cardiac arrhythmia, angina and kidney disease, autoimmune diseases like MS, rheumatism, etc, BMI> 40, factors causing secondary hypertension, supplementation of vitamin, mineral or other nutritional supplements, Alcohol or drug use, Incidence of severe side effects, non-compliance with study protocol
Age
From 35 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
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
Shahid Sadughi University of Medical Sciences and Health Services
Street address
Second Centeral Building of Shahid Sadughi University of Medical Sciences and Health Services, Shahid Bahonar square
City
Yazd
Postal code
891697847
Approval date
2010-10-26, 1389/08/04
Ethics committee reference number
79735/1/17/پ
Health conditions studied
1
Description of health condition studied
hypertension
ICD-10 code
I10
ICD-10 code description
High blood pressure
Primary outcomes
1
Description
IL6
Timepoint
At baseline, after the sixth week and twelfth week baseline
Method of measurement
ELISA
2
Description
hypertension
Timepoint
At At baseline, weeks after the sixth and twelfth week baseline
Method of measurement
Measured by standard mercury blood pressure measuring device sitting
3
Description
IL2
Timepoint
At baseline, after the sixth week and twelfth week baseline
Method of measurement
ELISA
4
Description
hs-CRP
Timepoint
At baseline, after the sixth week and twelfth week baseline
Method of measurement
ELISA
5
Description
TNF-a
Timepoint
At baseline, after the sixth week and twelfth week baseline
Method of measurement
ELISA
6
Description
Adiponectin
Timepoint
At baseline, after the sixth week and twelfth week baseline
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
Placebo, 100 mg, once daily for three months
Category
Placebo
2
Description
Coenzyme q10, 100 mg orally, once daily for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tuba Medical Center
Full name of responsible person
Street address
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadughi University of Medical Sciences and Health Services
Full name of responsible person
Hassan Mozaffari
Street address
3rd floor, Centeral Building of Shahid Sadughi University of Medical Sciences and Health Services, Shahid Bahonar sq.
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadughi University of Medical Sciences and Health Services
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
Shahid Sadughi University of Medical Sciences and Health Services
Full name of responsible person
Seied Mohammad Mohammadi Zarchi
Position
Assistant Professor of Endocrinology and Metabolism
Other areas of specialty/work
Street address
Shahid Sadughi University of Medical Sciences and Health Services,Yazd Diabetes Research Center
City
Yazd
Postal code
Phone
+98 912 346 8307
Fax
Email
drc@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadughi University of Medical Sciences and Health Services
Full name of responsible person
Dr Hassan Mozaffari
Position
PhD, Nutritionist
Other areas of specialty/work
Street address
3rd floor, Centeral Building of Shahid Sadughi University of Medical Sciences and Health Services, Shahid Bahonar sq.
City
Yazd
Postal code
Phone
+98 35 1724 9333
Fax
Email
mozaffari.kh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadughi University of Medical Sciences and Health Services
Full name of responsible person
Nasim Bagheri Nesami
Position
MS student of Health Science in Nutrition
Other areas of specialty/work
Street address
Shahid Sadughi University of Medical Sciences and Health Services
City
Yazd
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)