Evaluating the effect of L-carnitine on Quality of life of MS patients
Design
Clinical trial with randomized controlled trial, parallel group, double blinded, 140 patients. RALLOC module in Stata software will be used for randomization.
Settings and conduct
Patients are randomized in two groups. The intervention group will receive L-carnitine one gr twice a day and the placebo group will receive placebo. At the end of 2 month period, the SF-36 score and EDSS score will be evaluated again. and the effects of L-carnitine will be compared with placebo.
We will explain to the patients that their information will be kept private and if they won't like to continue the experiment, they can quit anytime.
The informed consent will be filled.The patients disability will be investigated with EDSS score by the investigator.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with RRMS، EDSS≤3.5 and aged between 18 to 60 years.
Exclusion criteria: Patients with hypothyroidism, EDSS≥4, GFR<30, allergic to L-carnitine and not interested in participating in the trail.
Intervention groups
The patients will be assigned randomly to the intervention either control group. The intervention group will receive L-Carnitine 1000mg tablets twice a day for a period of 2 months.
The control group will receive the placebo with the same appearance and dose for 2 months .
Main outcome variables
Investigation of L-carnitin on Quality of life in MS patients
Investigation of L-carnitin on EDSS score in MS patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220417054558N1
Registration date:2023-06-08, 1402/03/18
Registration timing:registered_while_recruiting
Last update:2023-06-08, 1402/03/18
Update count:0
Registration date
2023-06-08, 1402/03/18
Registrant information
Name
Afsoon Pooria
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3383 1907
Email address
pooria.a@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of L-carnitin on EDSS score and Quality of life of MS patients
Public title
The effect of L-carnitin on EDSS score and Quality of life of MS patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with RRMS
Patients with EDSS ≤ 3.5
Exclusion criteria:
Not interested in accompaniment the trial
Patients who have EDSS score equal to or higher than 4
Patients with hypothyroidism
Patients with severe renal failure of GFR<30
Who have a history of allergy to L-carnitine
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, permuted blocked randomization method will be used. Patients will be assigned to blocks of 28. A table of random numbers will be used to assign patients to drug or placebo groups.
5 random sequences, for 5 blocks of 28, will be built by RALLOC module in STATA software.
Sealed and matte envelopes will be used to conceal the allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
All participants, investigator and physicians will be blinded.
Patients who meet the inclusion criteria, will receive sealed and numbered envelopes and will be referred to a person who is responsible for delivering the product. The delivery person who is also blinded will be supposed to open the envelope and give product A or B to the participants.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz university of medical sciences
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2023-04-17, 1402/01/28
Ethics committee reference number
IR.TBZMED.REC.1402.081
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
The score of Quality of life in SF-36 questionnaire
Timepoint
Measurement of quality of life score after consumption of L-Carnitine for 2 months.
Method of measurement
SF-36 Questionnaire
Secondary outcomes
1
Description
EDSS score
Timepoint
Measurement of EDSS score after consumption of L-carnitine for 2 months.
Method of measurement
EDSS Questionnaire
Intervention groups
1
Description
Intervention group: L-carnitine 1 gr twice a day for two months (made by Karen food and pharma)
Category
Treatment - Drugs
2
Description
Control group: Placebo twice a day for two months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Afsoon Pooria
Street address
Neurology group office., Imam reza hospital of Tabriz., Daneshgah ave., Golgasht ave,
City
Tabriz
Province
East Azarbaijan
Postal code
1475651666
Phone
+98 41 3336 3177
Email
afsoonpooria@yahoo.com
2
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Afsoon Pooria
Street address
Neurology department., Razi hospital of Tabriz., Elgoli ave., Next to Shohada hospital,
City
Tabriz
Province
East Azarbaijan
Postal code
1475651666
Phone
+98 41 3380 4486
Email
afsoonpooria@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Parviz Shahabi
Street address
Tabriz, Golgasht st., Tabriz university of medical sciences, Central building No. 2, third floor of the vice chancellor for research and technology
City
Tabriz
Province
East Azarbaijan
Postal code
51664-14766
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
Parvizshahabi@gmail.com
Web page address
https://researchvice.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Afsoon Pooria
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Neurology group office., Imam reza hospital of Tabriz., Daneshgah ave.,Golgasht ave,
City
Tabriz
Province
East Azarbaijan
Postal code
1475651666
Phone
+98 41 3334 7054
Email
afsoonpooria@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Daryoush Savadi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Tabriz University of Medical Sciences,Attar Neyshabouri North, Golgasht street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 914 113 0185
Email
savadidaryoush@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Afsoon Pooria
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Neurology group office., Imam reza hospital of Tabriz., Daneshgah ave., Golgasht ave,
City
Tabriz
Province
East Azarbaijan
Postal code
1475651666
Phone
+98 41 3336 3177
Email
afsoonpooria@ yahoo.com
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
IPD will be available upon other researcher request via email to corresponding author, and following validation of the request.
When the data will become available and for how long
data will be available following study completion and without a time limit .
To whom data/document is available
to verified researchers following evaluation of their requests.
Under which criteria data/document could be used
following receipt of a signed form, and agreement note from publisher.
From where data/document is obtainable
data will be obtainable through publisher.
What processes are involved for a request to access data/document
the researcher should send a request to corresponding author and publisher.