Effect of L-carnitine supplementation on clinical status, anthropometric indices, and serum levels of some oxidative stress and inflammation biomarkers in ischemic stroke patients.
Effect of L-carnitine supplementation on clinical status, anthropometric indices, and serum levels of some oxidative stress and inflammation biomarkers in ischemic stroke patients.
Design
The clinical trial has a control group, with parallel groups, three blinded, randomized, on 82 case and control patients. The random number table will be used for randomization.
Settings and conduct
This study is conducted at Golestan Hospital, Jundishapur University of Medical Sciences, Ahvaz. 24 to 48 after the onset of symptoms, patients will be assigned by filling out a written consent form. Before the intervention and on the seventh day of the intervention, anthropometric measurements, TMT index, mRs and NIHSS indices are measured and blood samples are taken to test the serum levels of CRP, TAC, MDA and PAB index. All patients, the executive staff of the intervention and the people analyzing the results are unaware of the type of vial used in each group.
Participants/Inclusion and exclusion criteria
Diagnosis of ischemic stroke
Age above 18 years
BMI >18.5
NIHSS score greater than 10 and less than 22
The onset of symptoms is less than 24 hours.
No history of other neurological diseases
Having a focal neurological disorder
Intervention groups
The intervention group will receive three vials of 1000 mg L-carnitine daily and the placebo group will receive three 1000 mg vials of distilled water daily for 7 days.
Main outcome variables
Reduction of oxidative stress inflammation markers
Improvement of clinical condition and anthropometric indicators
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221206056734N1
Registration date:2023-02-11, 1401/11/22
Registration timing:registered_while_recruiting
Last update:2023-02-11, 1401/11/22
Update count:0
Registration date
2023-02-11, 1401/11/22
Registrant information
Name
Samaneh Hajjarzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3553 9049
Email address
hajarzadeh70@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of L-carnitine supplementation on clinical status, anthropometric indices, and serum levels of some oxidative stress and inflammation biomarkers in ischemic stroke patients.
Public title
Effect of L-carnitine in Ischemic Stroke
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosing and confirming the occurrence of ischemic stroke through clinical and neurological examinations by a neurologist and brain imaging (CT-Scan or MRI)
Be over 18 years old.
Body mass index be more than 18.5.
Having an NIHSS score of greater than 10 and less than 22.
The onset of symptoms be less than 24 hours.
Having focal neurologic deficit
Insensitivity to L-carnitine supplement
No history of previous stroke, craniotomy, and other CNS diseases such as seizures, epilepsy, brain tumor, severe brain injury, multiple sclerosis, Alzheimer's, Parkinson's, etc.
Not taking antioxidant or anti-inflammatory supplements or multivitamins in the last three months
Not suffering from chronic or acute liver and kidney disorders (kidney failure and dialysis)
Exclusion criteria:
Age
From 18 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:
82
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomly assign people to each of the studied groups, block randomization is used. For this study, 7 blocks of 10 and one block of 12 are considered, and an equal number of people from two intervention and control groups are entered in each block. The randomization unit for this study will be individual and for this purpose, a table of random numbers will be used.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Supplement and placebo are prepared by Pars Behrozan Jam pharmaceutical company and are labeled with two different letters. All patients, researchers, data analysts and outcome assessors are unaware of the contents of each label until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz JundiShapur University of Medical Sciences
Street address
Ahvaz, Golestan, North Esfand St., Ahvaz Jundishapur University of Medical Sciences, Faculty of Paramedicine
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2022-12-03, 1401/09/12
Ethics committee reference number
IR.AJUMS.REC.1401.416
Health conditions studied
1
Description of health condition studied
Ischemic stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
National Institutes of Health Stroke Scale (NIHSS) score
Timepoint
Before the intervention and on the seventh day of the intervention
Method of measurement
The scoring checklist is completed through clinical examinations by a specialist.
2
Description
Modified Rankin Scale (mRs) score
Timepoint
Before the intervention, on the seventh day of the intervention and three months after the intervention.
Method of measurement
The scoring checklist is completed through clinical examinations by a specialist.
3
Description
Temporal muscle thickness (TMT)
Timepoint
Before the intervention and on the seventh day of the intervention.
Method of measurement
Using ultrasound images
4
Description
C-reactive protein (CRP)
Timepoint
Before the intervention and on the seventh day of the intervention.
Method of measurement
blood test
5
Description
Total Antioxidant Capacity (TAC)
Timepoint
Before the intervention and on the seventh day of the intervention.
Method of measurement
blood test
6
Description
Malondialdehyde (MDA)
Timepoint
Before the intervention and on the seventh day of the intervention.
Method of measurement
blood test
7
Description
Pro-oxidant Antioxidant Balance (PAB)
Timepoint
Before the intervention and on the seventh day of the intervention.
Method of measurement
blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 41 patients with a diagnosis of stroke in the first 24 hours of hospitalization entered the study and will receive 3 vials of L-carnitine 1000 mg per day, prepared by Pars Behrouzan Jam Company, along with meals for 7 days. Patients receiving tube feeding will receive L-carnitine supplementation mixed into the gavage solution. Patients and executive staff will be unaware of the type of vial provided to patients.
Category
Treatment - Drugs
2
Description
Control group: 41 patients with a diagnosis of stroke in the first 24 hours of hospitalization entered the study and will receive 3 vials of double distilled water of 1000 mg per day prepared by Pars Behrouzan Jam Company along with meals for 7 days. Patients receiving tube feeding will receive placebo mixed into the gavage solution. Patients and executive staff will be unaware of the type of vial provided to patients.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan Hospital,َAhvaz Jundishapur University of Medical Sciences
Full name of responsible person
Samaneh Hajjarzadeh
Street address
Golestan, Esfand street
City
Ahvaz
Province
Khouzestan
Postal code
61357159
Phone
+98 61 3311 0000
Fax
Email
hajarzadeh70@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Majid Karandish
Street address
Farvardin Ave., Golestan Blvd, School of Allied Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3311 2538
Email
mkarandish@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Pars Behrouzan Jam Company
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Samaneh Hajjarzadeh
Position
Ph.D. candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Padad, 12th street, number 82
City
Ahvaz
Province
Khouzestan
Postal code
6183986642
Phone
+98 61 3553 9049
Email
hajarzadeh70@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Majid Karandish
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golestan, Esfand street, paramedical faculty of Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357159
Phone
+98 61 3311 2557
Email
mkarandish@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Samaneh Hajjarzadeh
Position
Ph.D candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
padad, 12th street, number 82
City
Ahvaz
Province
Khouzestan
Postal code
6183986642
Phone
+98 61 3553 9049
Email
hajarzadeh70@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
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