Survey the effect of resveratrol supplementation on some oxidative stress and inflammatory biomarkers, fatigue scale, fasting blood sugar and lipid profile in patients with Multiple Sclerosis.
Determination the effect of resveratrol supplementation on some oxidative stress and inflammatory biomarkers, fatigue scale, fasting blood sugar and lipid profile in patients with Multiple Sclerosis.
Design
A clinical trial with control group including a sample size of 60 people, with parallel group, double-blind, randomized
Settings and conduct
Referred to the Khouzestan MS Association in 2023, selection of 60 patients based on inclusion and exclusion criteria, randomization into intervention and control groups. Blinding of patients and researchers, coding by a third party who does not know the details.
Participants/Inclusion and exclusion criteria
The disease is diagnosed according to McDonald's criteria.
EDSS score 0 to 5
The clinical condition of the patient is relapse-remittance.
Age 18 to 65 years
The patient consumes alcohol, tobacco or drugs.
Use of antioxidant supplements and hormonal treatments.
Body mass index(BMI) higher than 30.
Any progressive or autoimmune diseases.
Intervention groups
Study groups include resveratrol and placebo consumer groups
Survey the effect of resveratrol supplementation on some oxidative stress and inflammatory biomarkers, fatigue scale, fasting blood sugar and lipid profile in patients with Multiple Sclerosis.
Public title
Resveratrol in multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The disease is diagnosed according to McDonald's criteria.
EDSS score 0 to 5
The clinical condition of the patient is relapse-remittance.
Age 18 to 65 years
Exclusion criteria:
The patient consumes alcohol, tobacco or drugs.
Use of antioxidant supplements and hormonal treatments.
Body mass index(BMI) higher than 30.
Any progressive or autoimmune diseases.
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of patients to each of the study groups will be done using random block method and using blocks of six. The blocks are designed by the statistical consultant and each block contains A or B, which represents the group receiving the drug or placebo. Patients receive the type of treatment (A or B) according to the order of entering the study and in the order specified by the randomization blocks. Unit codes are also applied in both packages containing medicine or placebo in advance, which means, for example, the first person who meets the study entry criteria, if based on the block, should receive medicine A, from the general box containing medicine A, one can It is randomly removed and given to the patient (the two-digit number on the can may be, for example, 15).
The use of unit codes is based on the expert opinion of the statistics consultant and is used to prevent the breaking of A and B codes.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the double-blind method will be used to reduce the possibility of information bias. In this way, both the patients and the researchers will be kept unaware of the type of treatment assigned to the subjects. For this purpose, resveratrol and placebo packages will be divided into A and B groups by someone outside the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz. Golestan Bolvar. Jundishapur University of Medical Sciences. Research Assistance
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2023-03-11, 1401/12/20
Ethics committee reference number
IR.AJUMS.REC.1401.588
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Tumor Necrosis Factor Alpha (TNF-α)
Timepoint
Before and two months after intervention
Method of measurement
ELISA
2
Description
MDA
Timepoint
Before and two months after intervention
Method of measurement
ELISA
3
Description
fatigue scale
Timepoint
Before and two months after intervention
Method of measurement
MFIS questionnaire
Secondary outcomes
1
Description
Fasting Blood Sugar
Timepoint
Before and two months after intervention
Method of measurement
Enzymatic
2
Description
Lipid Profile (TC , TG, HDL, LDL)
Timepoint
Before and two months after intervention
Method of measurement
Enzymatic
Intervention groups
1
Description
Intervention group: 500 mg of resveratrol (in the form of two capsules made by Raha Company) for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: tow placebo per day (made by Raha company) for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Khouzestan MS Association
Full name of responsible person
Mazie Zilaee
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3336 2414
Email
zilaee-m@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mehrnoosh Zakerkish
Street address
Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Sara Keramatzadeh
Position
M.Sc student of Nutrition Science
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, School of Allied Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan St., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3571 5794
Email
Sarakeramatzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Marzie Zilaee
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, School of Allied Medical Sciences, Jundishapur University of Medical Sciences, Golestan St., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 2713
Email
zilaee-m@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Sara Keramatzadeh
Position
M.Sc student of Nutrition Science
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Department of Nutrition, School of Allied Medical Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan St., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3311 2713
Email
Sarakeramatzadeh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The person's information will be confidential and the results will be as collective statistics
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available