Protocol summary
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Study aim
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determining the effect of L-carnitine supplement on fatigue severity in patients with multiple sclerosis
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Design
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Clinical trial with control group, with 2 parallel groups, double-blind, with 112 patients in total, 56 patients in each group and randomized. The RALLOC module in Stata software will be used for randomization.
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Settings and conduct
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Patients in the intervention group will receive 2 grams of L-carnitine daily for 2 months, and patients in the control group will receive a placebo with the same appearance as L-carnitine tablets and the same amount. At the end of this period, FSS and MFIS will be received from all patients again and the effects of L-carnitine will be compared with placebo.In the present clinical trial study, the patient, physician, and researcher will be blind to being placed in drug or placebo groups.
The study site will be the Razi Hospital Neurology Clinic.
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Participants/Inclusion and exclusion criteria
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-Inclusion criteria:
Patients with RRMS, MFIS SCORE>38 or FSS>4, EDSS≤3.5 in age range between 18 to 60 years.
-Exclusion criteria:
Patients suffering from depression, Hypothyroidism, Severe renal impairment with GFR<30 mL/min and patient receiving medicines such as Anti-psychotics, MAO inhibitors, Benzodiazepines, TCAs, Anti-epileptics and Barbiturates.
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Intervention groups
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The Intervention group will receive L-carnitine tablets 2 grams daily for a period of 2 months.
The control group will receive a placebo with the same shape and appearance as the L-carnitine tablets and the same amount for a period of 2 months.
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Main outcome variables
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-Determination of the effects of L-carnitine supplement in comparison with placebo in improving the fatigue of MS patients based on FSS score
-Determining the effects of L-carnitine supplement compared with placebo in improving fatigue in MS patients based on MFIS score.
General information
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Reason for update
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The expected recruitment end date has been extended for three more months since more time is demanded.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20211031052928N1
Registration date:
2021-12-13, 1400/09/22
Registration timing:
prospective
Last update:
2022-12-29, 1401/10/08
Update count:
1
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Registration date
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2021-12-13, 1400/09/22
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-12-22, 1400/10/01
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Expected recruitment end date
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2023-03-21, 1402/01/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluating the effect of L-carnitine supplement on fatigue severity in patients with multiple sclerosis
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Public title
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L-carnitine in patients with MS
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with RRMS
FSS>4 or MFIS>38
EDSS≤3.5
Exclusion criteria:
EDSS≥4
Depression
Hypothyroidism
Patients receiving medicines like Antipsychotics, MAOi, Benzodiazepines, TCAs, Anti-seizures and Barbiturates
Severe kidney disfunction with GFR<30 ml/min
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
112
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In order to uniformize the distribution of patients in the drug and placebo groups, a randomized blocking method will be used so that patients are evenly distributed in the study groups. At the end of the study, the relationship between different factors and fatigue in patients will be evaluated using multivariate logistic regression method.
In this study, random allocation will be done by block randomization method with fixed size blocks with standard methods. The randomization steps will be as follows:
1- Creating a random sequence: Four random sequences for 4 blocks of 28 will be created using the RALLOC module in STATA software.
2- Allocation concealment Allocation coverage will be done using the method of closed matte envelopes with serial numbering.
3- Execution of allocation: The allocation will be performed by the person in charge of the clinical trial.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In the present clinical trial study, the patient, physician, and researcher will be blinded to being placed in drug or placebo groups.
The researcher will receive the drug product or placebo with a unique code for each patient. the researcher will receive the medicine or placebo in completely closed and invisible containers inside them and completely similar in appearance.
Patients will be divided to four blocks of 28-patients blocks using a random number table in drug or placebo groups.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-11-29, 1400/09/08
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Ethics committee reference number
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IR.TBZMED.REC.1400.900
Health conditions studied
1
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Description of health condition studied
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Fatigue in patients with Relapsing-remitting MS
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ICD-10 code
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G35
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ICD-10 code description
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Multiple sclerosis
Primary outcomes
1
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Description
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Fatigue
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Timepoint
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fatigue will be evaluated based on MFIS and FSS score before intervention and 2 months after
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Method of measurement
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Fatigue severity scale (FSS) and Modified fatigue impact scale (MFIS) Questionnaires
Intervention groups
1
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Description
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Intervention group: Receiving 2 L-carnitine tabletes (1000 mg tablets made by Karen pharma food and supplements) daily for a period of 2 months.
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Category
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Treatment - Drugs
2
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Description
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Control group:receiving placebo in the same shape and amount as L-carnitine tablets received by intervention group for a period of 2 months. The placebo will be produced by Pharmaceuticals Department of Tabriz university of medical science.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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IPD will be available upon other researcher request via email to corresponding author, and following validation of the request.
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When the data will become available and for how long
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data will be available following study completion and without a time limit .
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To whom data/document is available
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to verified researchers following evaluation of their requests.
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Under which criteria data/document could be used
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following receipt of a signed form, and agreement note from publisher.
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From where data/document is obtainable
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data will be obtainable through publisher.
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What processes are involved for a request to access data/document
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the researcher should send a request to corresponding author and publisher.
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Comments
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