Evaluation of the effect of vitamin C on frequency and severity of flu like syndrome in Multiple Sclerosis patients receiving beta interferon
Design
Controlled trial with intervention and control groups, parallel groups, triple blind study, randomized based on the permuted block technique with block size equal to four on the basis of Random allocation ratio software, third phase, 100 patients
Settings and conduct
Among the patients referred to the treatment centers affiliated to the Department of Neurology of Shiraz and Tehran University of Medical Sciences who meet the inclusion criteria, 100 people were included in the study and divided into intervention and control groups. Patient, researcher and analyzer don't know whether the patient is in intervention or control group and then a person who is trained by the researcher will give vitamin C to one group and placebo to the other group every night for three months. At the end of the first, second and third months of the study, all patients will be evaluated for flu like symptoms after receiving beta interferon (fever, chills, muscular pain, weakness). In fact, the patient scores each of his symptoms from 0 to 3 and at the end these scores are compared in both the intervention and control groups.
Participants/Inclusion and exclusion criteria
1.Patients who have Multiple Sclerosis according to McDonald criteria.
2.Beta-interferon is prescribed for them for the fist time.
Intervention groups
A 250 mg vitamin C tablet is given to intervention group every night for three months.
A placebo tablet is given to control group every night for three months.
Main outcome variables
Fever, Chills, Muscular pain, Weakness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211122053145N2
Registration date:2023-06-17, 1402/03/27
Registration timing:registered_while_recruiting
Last update:2023-06-17, 1402/03/27
Update count:0
Registration date
2023-06-17, 1402/03/27
Registrant information
Name
Maryam Poursadeghfard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3484 5794
Email address
poursadra@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-30, 1402/02/10
Expected recruitment end date
2023-08-01, 1402/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of vitamin C on frequency and severity of flu-like syndrome in multiple sclerosis patients receiving beta-interferon
Public title
Evaluation of the effect of vitamin C on flu-like syndrome in multiple sclerosis patients receiving beta-interferon
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have Multiple Sclerosis according to McDonald criteria.
Beta-interferon is prescribed for them for the first time.
Exclusion criteria:
Patients who don't want to participate in this project.
Patients that take vitamin C themselves.
Patients who receive drugs other than beta-interferon for treatment of Multiple Sclerosis.
Patients who have other autoimmune diseases or underlying diseases except Multiple Sclerosis.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into A and B groups through the randomization method based on the permuted block technique considering block size equal to four on the basis of Random allocation ratio software.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patient, researcher and analyzer don't know whether the patient is in intervention or control group and a person who is trained by the researcher will give vitamin C to one group and placebo to the other group.
Placebo
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
Shiraz University of Medical Sciences, Zand street, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2019-07-28, 1398/05/06
Ethics committee reference number
IR.SUMS.REC.1398.707
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
Severity of fever
Timepoint
The end of the first, second and third month
Method of measurement
Scoring from 0 to 3 by asking the patient (zero means no symptoms, one means mild symptoms, two moderate and three severe symptoms)
2
Description
Severity of chills
Timepoint
The end of the first, second and third month
Method of measurement
Scoring from 0 to 3 by asking the patient (zero means no symptoms, one means mild symptoms, two moderate and three severe symptoms)
3
Description
Severity of body pain
Timepoint
The end of the first, second and third month
Method of measurement
Scoring from 0 to 3 by asking the patient (zero means no symptoms, one means mild symptoms, two moderate and three severe symptoms)
4
Description
Severity of weakness
Timepoint
The end of the first, second and third month
Method of measurement
Scoring from 0 to 3 by asking the patient (zero means no symptoms, one means mild symptoms, two moderate and three severe symptoms)
5
Description
Severity of flu like syndrome
Timepoint
The end of the first, second and third month
Method of measurement
Total scores of fever, chills, body pain, weakness
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Daily intake of one 250 mg vitamin C chewable tablet made by Osve company for three months
Category
Rehabilitation
2
Description
Control group: Daily intake of a placebo pill similar to vitamin C made by Shiraz University of Medical Sciences pharmaceutical company for three months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Clinic
Full name of responsible person
Maryam Poursadeghfard
Street address
Imam Reza specialized and sub-specialized clinic, next to Namazi Hospital, Namazi Square, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3212 7000
Email
motahari@sums.ac.ir
2
Recruitment center
Name of recruitment center
Medical centers affiliated to the Neurology Department of Tehran University of Medical Sciences
Full name of responsible person
Maryam Poursadeghfard
Street address
Tehran University of Medical Sciences, Qods Corner, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1461884513
Phone
+98 21 6640 5357
Email
tumspr@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempour
Street address
Shiraz University of Medical Sciences, Zand Street, in front of Palestine Street, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
info@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
Maryam Poursadeghfard
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Central building of Shiraz University of Medical Sciences, Zand Street, in front of Palestine Street, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
poursadra@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Poursadeghfard
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
central building of Shiraz University of Medical Sciences, Zand Street, in front of Palestine Street, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
poursadra@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
maryam poursadegh fard
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neurology
Street address
Central building of Shiraz University of Medical Sciences, Zand Street, in front of Palestine Street, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
poursadra@gmail.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