Investigation of the effect of trehalose on Fatigue in patients with Multiple Sclerosis (MS)
Design
Triple-blind parallel randomized clinical trial with control group, on 60 patients.
Settings and conduct
Patients with multiple sclerosis (MS) who will refer to MS clinic of Ghaem Hospital, Mashhad, and met the inclusion criteria, will be enrolled to this study after informed consent. They will be divided randomly into two groups of intervention (trehalose) and control (placebo). The study period is 3 months. The mentioned outcomes will be assessed and compared between two groups at baseline and after 3 months.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:Suffering from multiple sclerosis (MS), At least 6 months under treatment for MS, Age more than 18, Suffering from fatigue, EDSS less or equal to 6, Satisfaction for participation in the research project, Ability to read.
Exclusion Criteria: Under treatment of depression.
Intervention groups
Intervention group: 10 gr Trehalose for 12 weeks.
Control Group: Placebo (succrose) for 12 weeks.
Main outcome variables
Primary outcome: Fatigue Score by Modified Fatigue Impact Scale (MFIS). Secondary outcomes: Quality of life by European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L), Depression and Anxiety by Hospital Anxiety and Depression Scale (HADS), Ability to walk by Multiple Sclerosis Walking Scale-12 (MSWS-12). All the mentioned outcomes will be assessed at baseline and after 3 months.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181022041407N8
Registration date:2024-08-14, 1403/05/24
Registration timing:prospective
Last update:2024-08-14, 1403/05/24
Update count:0
Registration date
2024-08-14, 1403/05/24
Registrant information
Name
Maryam Emadzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9262
Email address
emadzadehm@mums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2026-09-23, 1405/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of trehalose on Fatigue in patients with Multiple Sclerosis (MS)
Public title
The effect of trehalose on Fatigue in MS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from multiple sclerosis (MS)
At least 6 months under treatment
Age more than 18
Suffering from fatigue
EDSS less or equal to 6
Satisfaction for participation in the research project
Ability to read
Exclusion criteria:
Under treatment for depression
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be done using the block sizes of 2 and 4 with randomization websites such as sealedenvelope.com. After randomization, the type of treatment will be written with odds and even numbers (or A/B codes) in separate papers and placed in an opaque envelope or the paper will be wrapped so that no one can see inside the paper (allocation concealment). After obtaining informed consent from the participants, one paper will be taken in order and according to the noted code, the participants will be placed in one of the intervention or placebo groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
َAfter randomization, the patients will be placed in two groups of A/B (or odds/even codes) and will received the products similar in shape and color (blinding of participants). The physician who will give the products to participants, received the boxes of the products with randomized codes (so the physician is blind too). The information of the patients and theirs treatment groups will be written with randomized codes (A/B) (the blinding of the assessor). Data will be entered to the SPSS software with codes (the blinding of the analyzer).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Mashhad University of Medical Sciences
Street address
Ghoreshi Building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2024-06-22, 1403/04/02
Ethics committee reference number
IR.MUMS.REC.1403.133
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
Fatigue score
Timepoint
At baseline and after 12 weeks
Method of measurement
Using Modified Fatigue Impact Scale (MFIS)
Secondary outcomes
1
Description
Quality of life
Timepoint
At baseline and after 12 weeks
Method of measurement
Using European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L)
2
Description
Depression and anxiety
Timepoint
At baseline and after 12 weeks
Method of measurement
Using Hospital Anxiety and Depression Scale (HADS)
3
Description
Ability to walk
Timepoint
At baseline and after 12 weeks
Method of measurement
Multiple Sclerosis Walking Scale-12 (MSWS-12)
Intervention groups
1
Description
Intervention group: Trehalose 10 g per day for 12 weeks, made by Shaanxi Fruiterco Biotechnology Co.,Ltd.
Category
Treatment - Drugs
2
Description
Control group: Placebo (one sachet of sucrose per day for 12 weeks)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Multiple Sclerosis (MS) Clinic, Ghaem Hospital
Full name of responsible person
Mohammad Ali Nahayati
Street address
Ghaem Hospital, Ahmad Abad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 912 710 8617
Email
nahayatima@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreshi Building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Emadzadeh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Clinical Research Development Unit, Ghaem Hospital, Ahmadabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3841 7403
Email
maryamemadzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amihossein Sahebkar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Pharmaceutical biotechnology
Street address
School of Pharmacy, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948954
Phone
+98 51 3180 1100
Email
sahebkara@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Emadzadeh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Clinical Research Development Unit, Ghaem Hospital, Ahmadabad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3841 7403
Email
maryamemadzadeh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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