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The Effect of Combined Antioxidant Supplementation on Blood Antioxidants indices, Lipid Peroxidation, Lipid Profile and Clinical Outcomes in Female Patients with Rheumatoid Arthritis

Protocol summary

Summary
The aim of this study is to investigate the effect of combined antioxidant supplement on blood antioxidant levels, lipid peroxidation and clinical outcomes in female RA patients. The design of this study is uncontrolled before after study. The population of the study is 40 female with Rheumatoid Arthritis with ages between 40-60 years, having ACR criteria for RA, with constant treatment and drug therapy since 2 months ago, without diabetes mellitus, renal or hepatic disorders, Cushing syndrome who they do not smoke and not to expose with smokers daily at home and they should not take antioxidant supplements. The intervention will include taking one Selenplus capsule (Euro vital company, Germany) contains Selenium 50 mcg, Zinc 8 mg, Vitamin A 400 mcg, Vitamin C 125 mg, and Vitamin E 40mg daily for 3 months. The outcomes will be blood antioxidant indices, lipid profile, lipid peroxidation, serum arylesterase, clinical outcomes, dietary intake of energy and nutrients, weight, and body mass index and emotional stress level.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138901183655N1
Registration date: 2010-06-22, 1389/04/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-06-22, 1389/04/01
Registrant information
Name
Seyed Rafi Arefhosseini
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1444 4782
Email address
arefhosseinir@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice- Chancellor of Nutrition and Health Faculty in Tabriz University of Medical Sciences- Rheumatology Research Team of Medicine Faculty of Tabriz University of Medical Sciences
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2010-09-23, 1389/07/01
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Combined Antioxidant Supplementation on Blood Antioxidants indices, Lipid Peroxidation, Lipid Profile and Clinical Outcomes in Female Patients with Rheumatoid Arthritis
Public title
The Effect of Selenplus on Rheumatoid Arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: female rheumatoid arthritis patients who have ACR criteria 1987 for RA, age 40-60 yrs old, not changing the treatment protocol since 2 months prior to the study, mild to moderate disease severity, Exclusion criteria: Presence of diabetes mellitus, hypertension, thyroid dysfunction, renal diseases, hepatic disorders, or Cushing’s syndrome, smoking or exposure to passive smoking, changing treatment and drugs, receiving antioxidant supplements
Age
From 40 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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
In the design of this study, confounding factors such as: dietary intake of foods and nutrients, body mass index and emotional stress level will be measured before and after the antioxidant intervention for adjusting the relationship of these variables with study outcomes.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Research Vice- Chancellor of Tabriz University of Medical Sciences
Street address
Research Vice- Chancellor of Tabriz University of Medical sciences, Attar-e-Neishabori avenue, Golgasht avenue, Tabriz
City
Tabriz
Postal code
Approval date
2010-07-06, 1389/04/15
Ethics committee reference number
8912

Health conditions studied

1

Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M06.9
ICD-10 code description
Rheumatoid arthritis, unspecified

Primary outcomes

1

Description
Blood Antioxidant Indices
Timepoint
twice: before and after 3 months
Method of measurement
all of parameters(superoxide dismutase, glutathione peroxidase, catalase, Total antioxidant capacity) by means of enzymatic kits except for catalase(with chemical substances) in Tabriz Pharmaceutical Research Center

2

Description
Clinical Outcomes
Timepoint
twice: before and after 3 months
Method of measurement
by means of DAS-28 validated questionnaire

3

Description
Lipid Profile
Timepoint
twice: before and after 3 months
Method of measurement
all parameters as HDL-C- Total cholesterol- triglyceride with enzymatic kits except LDL-c ( by means of Friedwald formula)

4

Description
Lipid Peroxidation
Timepoint
twice: before and after 3 months
Method of measurement
by chemical substances in Tabriz Pharmaceutical Research Center

5

Description
Serum Arylesterase Enzyme
Timepoint
twice: before and after 3 months
Method of measurement
by chemical substances in Tabriz Pharmaceutical Research Center

Secondary outcomes

1

Description
Emotional Stress Level
Timepoint
twice: before and after 3 months
Method of measurement
by validated emotional stress questionnaire- assissted by MSc psychology practioner

2

Description
Dietary Intake of Energy, Nutrients and Comparison with RDA
Timepoint
twice: before and after 3 months
Method of measurement
by validated dietary questionnaires: FFQ and 24- hr recall questionnaire for 3 days- calculated by Nutritionist 3 software

3

Description
weight
Timepoint
twice: before and after 3 months
Method of measurement
weighed by digital scales with 0.1 kg sensitivity

4

Description
Body Mass Index (BMI)
Timepoint
twice: before and after 3 months
Method of measurement
calculated with Quetlet's formula(weight(kg)/(height*height(m)))

Intervention groups

1

Description
Selenplus capsule(Eurovital company of Germany): Selenium 50mcg, Zinc 8mg, Vitamin A 400mcg, Vitamin C125mg, Vitamin E 40mg daily for 3 month duration
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sheikh Al Raees Clinic of Tabriz
Full name of responsible person
Dr Sousan Kolahi
Street address
Azadi avenue, close to Golgasht avenue, Tabriz
City
Tabriz

2

Recruitment center
Name of recruitment center
Clinic of Tabriz, Sina Hospital
Full name of responsible person
Dr Sousan Kolahi
Street address
close to Maralan square, Azadi avenue, Tabriz
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Vice- Chancellor of Nutrition and Health Faculty in Tabriz University of Medical Sciences
Full name of responsible person
Dr Bahram Pourghasem Gargari
Street address
Nutrition and Health Faculty, Attar avenue, Golgasht avenue, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice- Chancellor of Nutrition and Health Faculty in Tabriz University of Medical Sciences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Rheumatology Research, Faculty of Medicine, Tabriz University of Medical Sciences
Full name of responsible person
Dr Alireza Khabbazi
Street address
Imam Reza Hospital, Attar -e- Neishabori avenue, Golgasht avenue, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rheumatology Research, Faculty of Medicine, Tabriz University of Medical Sciences
Proportion provided by this source
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
Nutrition and Health Faculty in Tabriz University of Medical Sciences
Full name of responsible person
Dr Seyed Rafi Arefhosseini
Position
PHD of nutritional biochemistry, Assistant Professor of Nutrition and Health Faculty
Other areas of specialty/work
Street address
Nutrition and Health Faculty- Attar-e- Neishabori avenue- Golgasht avenue- Tabriz
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
arefhosseinir@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Health and Nutrition Faculty in Tabriz University of Medical Sciences
Full name of responsible person
Dr Seyed Rafi Arefhosseini
Position
PHD of nutritional biochemistry, Assistant professor of Nutrition and health faculty
Other areas of specialty/work
Street address
Nutrition and Health Faculty- Attar-e- Neishabori avenue- Golgasht avenue- Tabriz
City
Tabriz
Postal code
Phone
+98 41 1335 7580
Fax
Email
arefhosseinir@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nutrition and Health Faculty in Tabriz University of Medical Sciences
Full name of responsible person
Mahsa Jalili
Position
MSc student of nutrition
Other areas of specialty/work
Street address
no 15, Gandom alley, 22bahman avenue, Tabriz
City
Tabriz
Postal code
5178647961
Phone
+98 41 1444 4782
Fax
Email
jalili.mah@hotmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
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Clinical Study Report
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Analytic Code
empty
Data Dictionary
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