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Effects of Quercetin on plasma total antioxidant capacity, lipid peroxidation, blood pressure, inflammatory markers and disease activity in patients with Rheumatoid Arthritis

Protocol summary

Summary
The present study is a double-blind, placebo-controlled, randomized trial to investigate the effect of Quercetin on plasma total antioxidant capacity, Malondialdehyde and oxidized- LDL, blood pressure, inflammatory factors and disease activity in patients with Rheumatoid Arthritis. Fifty Rheumatoid Arthritis patients will be recruited and randomly assigned to receive either Quercetin, 500 mg in the form of capsules, or placebo for 8 weeks. Plasma level of MDA, ox-LDL, systolic & diastolic pressure, TAC, hs-CRP, hs-TNFα, disease activity score, physician global assessment, morning stiffness, ESR, RF, assessment of pain by VAS and in order to controlling the confounding factors, weight, height, BMI, 24-h dietary recall, disease duration and severity, drugs type and dosage, physical activity will be measured at the baseline and the end of the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138807252394N2
Registration date: 2010-03-13, 1388/12/22
Registration timing: prospective

Last update:
Update count: 0
Registration date
2010-03-13, 1388/12/22
Registrant information
Name
Shima Jazayeri
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4805
Email address
sjazayeri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Research, Iran University of Medical Sciences
Expected recruitment start date
2010-04-21, 1389/02/01
Expected recruitment end date
2011-04-21, 1390/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Quercetin on plasma total antioxidant capacity, lipid peroxidation, blood pressure, inflammatory markers and disease activity in patients with Rheumatoid Arthritis
Public title
Effects of Quercetin on plasma total antioxidant capacity, lipid peroxidation, blood pressure, inflammatory markers and disease activity in patients with Rheumatoid Arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Willing to participate in study, Clinical diagnosis of AR (meeting the American college of rheumatology 1987 criteria), Ages between 19 – 70 years , No smoking or addiction , No drug type and dose fluctuation since 1 month prior to the study and during intervention period , Not having severe cardiovascular, hepatic, kidney, gastrointestinal, thyroid, parathyroid diseases, diabetes and inflammation, Not using medications except for AR conventional drugs, Not using antioxidant supplements during last month, No pregnancy or lactation Exclusion criteria: Compliance less than 70%, Disinclination to continue for cooperation, developing illnesses which need particular cures or interfere with intervention such as increasing the disease activity or trauma
Age
From 19 years old to 70 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

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of school of health, Iran university of medical sciences
Street address
school of Health, Arjantin Square, Alvand Ave., Tehran
City
Tehran
Postal code
1516846514
Approval date
empty
Ethics committee reference number
3248

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

Primary outcomes

1

Description
total antioxidant capacity (TAC)
Timepoint
8 weeks
Method of measurement
colorimetric assay

2

Description
hs-TNF-alpha
Timepoint
8 weeks
Method of measurement
ELISA

3

Description
hs- CRP
Timepoint
8 weeks
Method of measurement
ELISA

4

Description
ox-LDL
Timepoint
8 weeks
Method of measurement
ELISA

5

Description
Malondialdehyde
Timepoint
8 weeks
Method of measurement
chemical colorimetric

6

Description
disease activity score- 28 joints(DAS-28)
Timepoint
8 weeks
Method of measurement
Physical examination

7

Description
morning stiffness
Timepoint
8 weeks
Method of measurement
question

8

Description
blood pressure
Timepoint
8 weeks
Method of measurement
sphyngomanometer

Secondary outcomes

1

Description
rheumatoid factor(RF)
Timepoint
8 weeks
Method of measurement
turbidometric assay

2

Description
eritrocyte sedimentation rate(ESR)
Timepoint
8 weeks
Method of measurement

Intervention groups

1

Description
Quercetin supplement, 500 mg caps per day for 8 weeks
Category
Treatment - Drugs

2

Description
placebo caps for 8 weeks
Category
empty

Recruitment centers

1

Recruitment center
Name of recruitment center
rheumatology clinic of Firuzgar hospital
Full name of responsible person
Dr. Mojdeh Zabihi
Street address
City
Tehran

2

Recruitment center
Name of recruitment center
rheumatology clinic of Loghman hospital
Full name of responsible person
Dr. Arman Ahmadzadeh
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran Univesity of Medical Sciences
Full name of responsible person
Dr Mohsen Asadi Lari
Street address
Iran University of Medical Sciences, Hematt express 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 Univesity 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
School of Health, Iran University of Medical Sciences
Full name of responsible person
Dr. Shima Jazayeri
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Health, Alvand Ave, Arjantin Sq
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
s.jazayeri@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Health, Iran University of Medical Sciences
Full name of responsible person
Dr. Shima Jazayeri
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Health, Alvand Ave, Arjantin square
City
Tehran
Postal code
Phone
+98 21 8877 9118
Fax
Email
s.jazayeri@iums.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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