Comparison of the effectiveness of selenium with placebo on disease activity and inflammatory factors and oxidative stress in patients with rheumatoid arthritis
The aim of this study is to determine the effect of selenium supplementation on disease activity and inflammatory factors and oxidative stress in rheumatoid arthritis patients
Design
A double-blind placebo-controlled clinical trial. Patients will be assigned to either a selenium supplement (n = 30) or a placebo (n = 30).
Settings and conduct
Among the patients with rheumatoid arthritis referred to the Beheshti Clinic, 60 patients will be selected based on inclusion and exclusion criteria. Participants and researchers are unaware of the allocation of study groups. Supplement and placebo tablets are similar in shape and size. Fasting blood samples will be taken from patients at baseline and 12 weeks after intervention
Participants/Inclusion and exclusion criteria
rheumatoid arthritis patients; ages 18 to 75 years who Exclusion criteria: Patients with infectious diseases, concomitant rheumatologic disease or hypertension
Intervention groups
Intervention group: 200 μg daily selenium for 12 weeks. Control group: placebo tablet daily for 12 weeks
Main outcome variables
Changes in disease activity, changes in clinical symptoms, lipid profiles, inflammatory factors, and changes in oxidative stress biomarkers
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190924044869N1
Registration date:2020-06-14, 1399/03/25
Registration timing:registered_while_recruiting
Last update:2020-06-14, 1399/03/25
Update count:0
Registration date
2020-06-14, 1399/03/25
Registrant information
Name
Fereshteh Taghvaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5531 6850
Email address
sedaghat_h@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-12-20, 1399/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of selenium with placebo on disease activity and inflammatory factors and oxidative stress in patients with rheumatoid arthritis
Public title
Effect of Selenium supplementation in rheumatoid arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with active rheumatoid arthritis
aged 18 to 75 years.
Exclusion criteria:
active infection
high and moderate blood pressure (systolic pressure less than 140 and diastolic pressure less than 90 mmHg)
smoking
concurrent rheumatologic disease
Hypothyroidism or hyperthyroidism
Kidney or liver failure
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 66 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients were randomly assigned into each intervention group by their numbers. The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes. Supplements and placebos are in the same packaging at the Pharmaceutical company. Only the code is written on the packages. Patients and researchers do not know the type of intervention and after analyzing the data, packet codes are decoded.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
committee of Kashan University of medical sciences
Street address
Ghotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2020-02-03, 1398/11/14
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1398.129
Health conditions studied
1
Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M05
ICD-10 code description
Rheumatoid arthritis with rheumatoid factor
Primary outcomes
1
Description
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
2
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
3
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
4
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
Fasting plasma glucose
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
6
Description
HDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
7
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
8
Description
Nitric oxide
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive one Selenium tablet 200 microgram tablet daily for 12 weeks.
Category
Treatment - Drugs
2
Description
The control group will receive one placebo tablet daily for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Batol Zamani
Street address
Qotb-e-Ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0026
Email
zamani-b@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Street address
Qotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Email
research@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fereshte Taghvaee
Position
Associate
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Qhotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0021
Email
fsh.taghvaee@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Nasrin Sharifi
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qhotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5562 0608
Email
sharifi-na@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Fereshte Taghvaee
Position
Associate
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ghotbe Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0021
Email
fsh.taghvaee@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
A portion of the data regarding demographics, anthropometric, and food variables, that are collected at the baseline of the study, and also the information on the main outcome will be shared.
When the data will become available and for how long
The start of the data access period will be one year after the publication of the result.
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
In order to conduct meta analysis studies
From where data/document is obtainable
Nasrin Sharifi, Nutrition Department, School of Medicine, Kashan University of Medical Sciences, Qotbe-e-Ravandi Blvd., Kashan, Iran Postal Code: 88715973474 E-mail: sharifi-na@kaums.ac.ir Tel: 00983155540021 Fax: 00983155620608
What processes are involved for a request to access data/document
An applicant can send a request for a data file by e-mail. After reviewing the request, the data file will be sent to him/her after about three weeks would have passed from the date of the request