The goal of this study is to evaluate the effect of combination antioxidant supplementation on blood ADMA and VEGF levels and clinical outcomes in patient with rheumatoid arthritis. This study is single bind. Sample size is 40. All subjects before the intervention being examined for their disease activity (DAS. After 3 months subjects will be examined and assess DAS to determine the intervention effect. An exclusion criterion is changing method of treatment. Before starting the study, blood samples were taken from all participants after 12-8 h fasting and approximately 5 ml of venous blood was obtained. After the intervention period (3 months) patient's blood samples will be taken again. Patients' blood, VEGF, ADMA with rheumatoid arthritis is to measure to determine the possible effect of interventions on blood VEGF, ADMA.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203116934N2
Registration date:2012-05-30, 1391/03/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-05-30, 1391/03/10
Registrant information
Name
Susan Kolahi
Name of organization / entity
Tabriz Medical Science University
Country
Iran (Islamic Republic of)
Phone
+98 914 310 4072
Email address
kolahis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Pharmaceutical research center, Tabriz University of Medical Sciences
Expected recruitment start date
2012-06-20, 1391/03/31
Expected recruitment end date
2012-09-20, 1391/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combinant antioxidant supplementation on blood ADMA and VEGF levels and clinical outcomes in patient with rheumatoid arthritist
Public title
The effect of combinant antioxidant supplementation on blood in patient with rheumatoid arthritist
Purpose
Treatment
Inclusion/Exclusion criteria
People with diagnosis of Rheumatoid arthritis disease according to American College of Rheumatology criteria (ACR) is confirmed. The doctor diagnosed according to criteria ACR (at least 4 criteria for six weeks : 1 - morning stiffness in the joint for at least an hour or more 2 - articular arthritis in three areas or more4: hand joint arthritis 5- symmetrical arthritis 5 - rheumatoid nodules 6 - positive rheumatoid factor 7 - typical radiographic changes in the wrist and hand) in adult patients with rheumatoid arthritis and patients visiting the doctor, at least for the past two months have not had a treatment change. Selected at random from among eligible women 30 -60 years old admitted with mild to moderate range of severity of illness would be a specialist; if DAS (Disease Activity Score) below 3/2 is a mild disease and the DAS (Disease Activity Score) is between 3/2-5/1, moderate severity is defined .
Age
From 30 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences Ethics Committee
Street address
Tabriz University of Medical Sciences Building, 3rd Floor Research
City
Tabriz
Postal code
Approval date
2011-10-28, 1390/08/06
Ethics committee reference number
921
Health conditions studied
1
Description of health condition studied
Rhumatoid arthritis
ICD-10 code
MO5
ICD-10 code description
Seropositive rheumatoid arthritis
Primary outcomes
1
Description
Determine and compare the clinical improvement in patients with rheumatoid arthritis before and after intervention
Timepoint
Before and 3 month after intervention
Method of measurement
DAS questionnaire
2
Description
ADMA concentrations in the serum of patients with rheumatoid arthritis before and three months after the administration of antioxidants
Timepoint
Previous intervention three months after the intervention began
Method of measurement
ELISA method
3
Description
Determine changes in serum VEGF rheumatoid arthritis before and three months after the administration of antioxidants
Timepoint
Before and 3 month after intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
Investigate the effects of antioxidant drugs
Timepoint
Before and three months after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
A tablet supplementation antioxidant compounds, including supplementation with a combination of selenium, zinc, vitamin A, E and C to form oral supplement "Celine Plus" is the order of 50 mg, 8 mg, 400 mg, 40 mg and 125 mg are. will be given to patients after Q Miran disease activity ADMA, VEGF was measured before and after study
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized medical clinics
Full name of responsible person
Susan Kolahi
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pharmaceutical research center, Tabriz University of Medical Sciences
Full name of responsible person
Babayi hossein
Street address
Pashmine bulding , Daneshgah avenue
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pharmaceutical research center, Tabriz 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
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sousan Kolai
Position
Associate professor
Other areas of specialty/work
Street address
rheumatology departmant,imam reza hospital
City
Tabriz
Postal code
Phone
+98 41 1337 1217
Fax
Email
susan.kolahi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pharmaceutical Research Center
Full name of responsible person
Sousan Kolahi
Position
MD, Rheumatology subspecialist
Other areas of specialty/work
Street address
Imam Reza hospital, Golgasht Avenue
City
Tabriz
Postal code
Phone
+98 41 1337 1217
Fax
Email
susan.kolahi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sousan Kolahi
Position
Associate professor
Other areas of specialty/work
Street address
Imam Reza hosoital, Glughashat Avenue
City
Tabriz
Postal code
5163984974
Phone
+98 41 1337 1217
Fax
+98 41 1337 1217
Email
susan.kolahi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)