the effect of vitamin C on flu-like syndrome in MS patient after starting beta-interferon
Design
A randomized clinical trial, triple-blind, placebo-controlled
Settings and conduct
The present study will be conducted as a clinical trial on MS patients receiving interferon, after permission from the Ethics Committee of Shiraz University of Medical Sciences. Patients will be randomly divided into two groups. Treatment group: receiving vitamin C 250mg after admission for 3 months. 2. Placebo group: receiving vitamin C-like pills with starch content for 3 months. All patients will be evaluated at the end of each months for symptoms of flu-like syndrome such as fever, chills and muscle pains, and the severity of the syndrome. Flu-like syndrome symptoms score is used to evaluate patients to achieve FLS-S. Each patient scores for each symptom, and each symptom is evaluated separately. 0 = no sign, 1 = mild (no disruption in daily activities), 2 = moderate (partial disruption in daily activities), 3 = severe (need to rest at home). The scores of each symptom is calculated and summed with other symptoms, such that the FLS-S scores between 0 and 12, and the severity of the syndrome is classified according to the following scale: Mild: 0-4 Medium: 5-8, Severe: 9-12. At the end, the mean of three scores is calculated and measured in each month and then compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:MS Patients who are taking interferon for the first time.
Exclusion criteria: MS patients who have undergone interferon therapy for some time. Patients who do not wish to participate in the project.
Intervention groups
MS patients receiving interferon that are divided into two groups receiving Vit C and placebo.
Main outcome variables
symptoms of flu-like syndrome such as fever, chills and muscle pains, as well as the severity of the syndrome.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190731044396N1
Registration date:2019-10-02, 1398/07/10
Registration timing:registered_while_recruiting
Last update:2019-10-02, 1398/07/10
Update count:0
Registration date
2019-10-02, 1398/07/10
Registrant information
Name
Maryam poursadeghfard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 1065
Email address
poursadegh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-03-05, 1398/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin C on flu-like syndrome in MS patient after starting beta-interferon
Public title
The effect of vitamin C on flu-like syndrome in MS patient
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
MS patients based on the McDonald's 2017 Criterion, taking interferon for the first time.
Exclusion criteria:
A patient with MS who has been on the interferon therapy for some time
Patients who do not wish to participate in the study.
Age
From 20 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
patients were divided into control and case groups using permutation block randomization method with block size equal to 4, randomization list was generated based on Random allocation ratio software.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study is a triple-blind study. Neither the researcher nor the analyzer are aware of the patient being placed in the case or control group. The other person who trained by researcher, gives placebo or Vit C, which are similar in appearance and taste to the main drug (interferon ), and both of them are stored at room temperature. After selecting Vit C and placebo groups, each patient in case group will receive a 250mg Vit C chew-able tablet each night from the Osveh and Patients in control group will receive a placebo-coated tablet similar to the Vit C tablet that are studied by Shiraz Pharmacy School.
Placebo
Used
Assignment
Other
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
Zand Street, Shiraz University of Medical Sciences
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
FLS in MS Pt that receives beta interferon
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fever and chills, weakness, muscle body pain
Timepoint
first, second and third months
Method of measurement
flu like syndrome symptoms score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: administration of daily Vit C (250mg) for 3 months
Category
Rehabilitation
2
Description
Control group: administration of daily placebo tablets for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina clinic and Emam Reza clinic
Full name of responsible person
Maryam Poursadegh fard
Street address
Zand street, Emam Reza Clinic
City
Shiraz
Province
Fars
Postal code
71473771348
Phone
+98 71 3212 7000
Email
poursadegh@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Younes.Ghasemy
Street address
Zand Street, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
poursadegh@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
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Karim khane zand Blvd, namazi, motahari clinic
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3612 1065
Fax
Email
Poursadegh@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Poursadeghfard
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Karim khane zand Blvd, namazi, motahari clinic
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3612 1065
Fax
Email
Poursadegh@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Poursadeghfard
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Karim khane zand Blvd, namazi, motahari clinic
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3612 1065
Fax
Email
Poursadegh@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Part of the data is the main consequence of the study
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
Researchers working in academia and industry
Under which criteria data/document could be used
Supporting use
From where data/document is obtainable
Dr. Maryam Poursadegh fard
poursadegh@sums.ac.ir
What processes are involved for a request to access data/document
After submitting the request and checking the available items,The data is obtained