Comparison the effect of coenzyme Q10 and placebo on clinical sings, inflammatory factors, matrix metalloproteinases and oxidative status in rheumatoid arthritis patients
The purpose of this randomized controlled trial is to investigate the effect of coenzyme Q10 (Co Q10) supplementation on clinical sings, inflammatory factors, matrix metalloproteinases and oxidative status in rheumatoid arthritis patients. According to the American College of Rheumatology criteria, 50 patients with moderate and severe disease who treat with fixed doses of Disease Modifying Anti-Rheumatic Drugs will be included. Patients who are taking antioxidants or omega 3 fatty acids supplements and have liver disease, kidney disease and diabetes should be excluded. Patients will be assigned to intervention or control group via randomized blocks. 25 patients in intervention group will consume daily a 100 mg-capsul of Coenzyme Q 10 and 25 patients in control group will consume placebo for two months. Demographic data will be collected at baseline. Patients will be asked to complete food record questionnaires for three days in the first week and three days in the last week of the study to assess food intakes. Before and after intervention, Disease Activity Score and Health Assessment Questionnaire will be completed for each patient. At the beginning and end of the study 7 ml of venous blood will be taken from patients after 12 hours of fasting to measure the serum levels of interleukin-6, tumor necrosis factor-alpha, matrix metalloproteinase 1, matrix metalloproteinase 3, total antioxidant capacity and malondialdehyde.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201311014105N16
Registration date:2013-12-16, 1392/09/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-12-16, 1392/09/25
Registrant information
Name
Beit Allah Alipour
Name of organization / entity
Health & Nutrition Faculty
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
alipourb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-12-21, 1392/09/30
Expected recruitment end date
2014-06-20, 1393/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of coenzyme Q10 and placebo on clinical sings, inflammatory factors, matrix metalloproteinases and oxidative status in rheumatoid arthritis patients
Public title
Effect of CoQ10 on rheumatoid arthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria:
Disease diagnosis based on ACR criteria by expert; Fixed type and dose of drugs one month before intervention to the end of the study; Under treatment with DMARDs (Hydroxychloroquine, Prednisone, Methotrexate, Sulfasalazine, and ...); Patients with moderate and severe disease; Catching RA disease at least six months ago; Age between 18 to 65 years; Consent to participate in the study
Exclusion criteria:
Simultaneously participate in trials of other investigators; Pregnancy or the decision to become pregnant during the study period; Breastfeeding; Taking contraceptive drugs; Consumption of antioxidant supplements (A, C, E); Consumption of omega-3 fatty acids; Having liver, kidney, thyroid, diabetes, or infectious disease; Taking anticoagulants such as warfarin; Smoking or repeated exposure to smoking; Drug addiction; Not wanting to continue; Less than 70% adherence
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In this study, patients and researcher are unaware of the kind of intervention (coenzyme Q10 or placebo) in groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht street, Tabriz
City
Tabriz
Postal code
Approval date
2013-10-21, 1392/07/29
Ethics committee reference number
92113
2
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Urmia University of Medical Sciences, Emergency Alley, Resalat Boulevard, Orumieh
City
Orumieh
Postal code
Approval date
2013-11-05, 1392/08/14
Ethics committee reference number
umsu.rec.1392.152
Health conditions studied
1
Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M05
ICD-10 code description
Seropositive rheumatoid arthritis
2
Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M06
ICD-10 code description
Other rheumatoid arthritis
3
Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M08
ICD-10 code description
Juvenile arthritis
Primary outcomes
1
Description
Malondialdehyde (MDA)
Timepoint
At baseline and 2 months after intervention
Method of measurement
Spectrophotometry
2
Description
Matrix metalloproteinase 1 (MMP-1)
Timepoint
At baseline and 2 months after intervention
Method of measurement
MMP-1 kit
3
Description
Matrix metalloproteinase 3 (MMP-3)
Timepoint
At baseline and 2 months after intervention
Method of measurement
MMP-3 kit
4
Description
Total antioxidant capacity (TAC)
Timepoint
At baseline and 2 months after intervention
Method of measurement
TAC kit
5
Description
Interleukin 6 (IL-6)
Timepoint
At baseline and 2 months after intervention
Method of measurement
IL-6 kit
6
Description
Tumor necrosis factor alpha (TNF-α)
Timepoint
At baseline and 2 months after intervention
Method of measurement
TNF-α kit
7
Description
Health status
Timepoint
At baseline and 2 months after intervention
Method of measurement
Questionnaire
8
Description
Disease activity
Timepoint
At baseline and 2 months after intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
High density lipoprotein (HDL)
Timepoint
At baseline and 2 months after intervention
Method of measurement
HDL kit
2
Description
Triglyceride (TG)
Timepoint
At baseline and 2 months after intervention
Method of measurement
TG kit
3
Description
Cholesterol
Timepoint
At baseline and 2 months after intervention
Method of measurement
Cholesterol kit
4
Description
Low density lipoprotein (LDL)
Timepoint
At baseline and 2 months after intervention
Method of measurement
Calculate with the friedewald equation
5
Description
Body mass index (BMI)
Timepoint
At baseline and 2 months after intervention
Method of measurement
Calculation
Intervention groups
1
Description
Patients in intervention group will receive daily one 100 mg capsule of Coenzyme Q10 with meal for two months
Category
Treatment - Drugs
2
Description
Patients in control group will receive daily one capsule of placebo with meal for two months