Effect of anti-inflammatory diet on inflammatory markers , oxidative stress , disability, fatigue and quality of life in relapsing-remitting multiple sclerosis patient
Effect of anti-inflammatory diet on inflammatory markers, oxidative stress, disability, fatigue and quality of life in relapsing-remitting multiple sclerosis patient
Design
In this clinical trial with parallel groups , 120 eligible relapsing-remitting multiple sclerosis patients will be chosen.Then participants will randomly divided to intervention and control groups and a code will be assigned to each of them
Settings and conduct
Intervention group , antiinflammatory diet based on antiinflammatory diet pyramid and control group will received healthy diet recommendations.This study will be conducted in MS research center affiliated to Shiraz University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Age 20-40 years;
EDSS <5.5;
Voluntary cooperation;
Clinical course of relapsing-remitting;
Use of a particular diet during the last 3 months before entering the study
Intervention groups
Relapsing-remitting multiple sclerosis patients
Main outcome variables
Change in disability score ( EDSS) ; change in fatigue score (MFIS) ; change in quality of life ( MSQOL-54 ) ; change in IL17 ; change in IL4 ; change in hs-CRP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171217037916N2
Registration date:2018-09-05, 1397/06/14
Registration timing:registered_while_recruiting
Last update:2018-09-05, 1397/06/14
Update count:0
Registration date
2018-09-05, 1397/06/14
Registrant information
Name
Zahra Mousavi Shirazi Fard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 1540
Email address
z_mousavi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-22, 1397/04/31
Expected recruitment end date
2019-01-19, 1397/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of anti-inflammatory diet on inflammatory markers , oxidative stress , disability, fatigue and quality of life in relapsing-remitting multiple sclerosis patient
Public title
Effect of diet on multiple sclerosis patient
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20-50 years
EDSS<5.5
Voluntary cooperation
Clinical course of relapse-remitting
Exclusion criteria:
Use of a particular diet during the last 3 months before entering the study
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences , Zand St.
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2018-05-08, 1397/02/18
Ethics committee reference number
IR.SUMS.REC.1397.140
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
Disability
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Expanded disability status scale
2
Description
Fatigue
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Modified fatigue impact scale
3
Description
Quality of life
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Multiple Sclerosis Questionnaire of Life-54
4
Description
hs-CRP
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Laboratory kit
5
Description
IL17
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
ELISA
6
Description
IL4
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
Total antioxidant capacity
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Laboratory kit
2
Description
Glutathione
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Laboratory kit
3
Description
Malondialdehyde
Timepoint
Before intervention and 12 weeks after intervention
Method of measurement
Laboratory kit
Intervention groups
1
Description
Intervention group: anti-inflammatory diet
Category
Lifestyle
2
Description
Control group: healthy diet recommendation
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
مرکز تحقیقات ام اس
Full name of responsible person
Dr. Sadegh Izadi
Street address
Chamran hospital , Chamran Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
71347-14335
Phone
+98 71 3623 4507
Email
shirazifard1393@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Basir Hashemi
Street address
Central building of Shiraz University of Medical Sciences , Zand St., Shiraz
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Email
hashemib@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr, zohreh Mazloom
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Razi s.t, Shiraz
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71372510015
Email
z_mousavi@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Zohreh Mazloom
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Razi s.t, Shiraz
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71372510015
Email
z_mousavi@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Mousavi Shirazi Fard
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
School of Nutrition and Food Sciences, Razi s.t, Shiraz
City
Shiraz
Province
Fars
Postal code
7153675541
Phone
+98 71372510015
Email
z_mousavi@sums.ac.ir
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
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
Title and more details about the data/document
Information about the assessment of disability, fatigue and quality of life after the unidentifiable participant is unobtrusiv
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Study data will only be available to researchers working in academic and academic institutions