To survey the effect of L-carnitine supplement on frailty index in liver cirrhotic adult patients and compare to control group: A double-blind randomized control trial
Determining the effect of L-carnitine supplementation on frailty index in adult liver cirrhotic patients
Design
This study is a double-blind, randomized controlled trial with a parallel-group conducted on adult cirrhotic patients in Shiraz Abu Ali Sina Hospital (Shiraz Organ Transplantation Center). In this study, the effect of L-carnitine on the frailty index in patients with liver cirrhosis will be investigated. The intervention group consisted of 35 patients taking L-carnitine with conventional medications and the control group of 35 patients receiving only conventional medications.
Settings and conduct
This study is a double-blind, randomized controlled clinical trial using L- carnitine supplementation among adult patients with liver cirrhosis in the clinic of Shiraz Bu Ali Sina Hospital.
The medical students and a gastroenterologist will examine the patient and evaluate the laboratory tests, and frailty index under blinded conditions.
The data analyzer is also unaware of case and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Adult patients(18-50 years old), Cirrhotic patients
Exclusion criteria: Overt hepatic encephalopathy, Consumption of L-carnitine supplement in the last year, Hepatocellular carcinoma, Decompensated cirrhosis, MELD more than 20, HbA1c more than7
Intervention groups
The dose of L-carnitine 500 mg orally three times a day for two months will be given to the patient along with the conventional medication regimen.
the control group with a sample size of 35 cirrhotic patients who were matched with the intervention group based on age, sex, underlying disease, and MELD score taking the conventional medication regimen.
Main outcome variables
Liver frailty index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200628047940N2
Registration date:2022-06-14, 1401/03/24
Registration timing:registered_while_recruiting
Last update:2022-06-14, 1401/03/24
Update count:0
Registration date
2022-06-14, 1401/03/24
Registrant information
Name
Nasrin Motazedian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 1529
Email address
nmotazedi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-30, 1400/11/10
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To survey the effect of L-carnitine supplement on frailty index in liver cirrhotic adult patients and compare to control group: A double-blind randomized control trial
Public title
L-carnitine supplement in end-stage liver disease adult patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients(18-50 years old)
Cirrhotic patients
Exclusion criteria:
Overt hepatic encephalopathy
Consumption of L-carnitine supplement in the last year
Hepatocellular carcinoma
Decompensated cirrhosis
MELD more than 20
HbA1c more than7
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with liver cirrhosis who refer to the inpatient clinic of Abu Ali Sina Transplant Hospital, are examined by a gastroenterologist. If they have inclusion criteria and are willing to participate in the study, they are referred to a medical student to record patient information and measure the frailty index. Patients go to the pharmacy to receive medicine. The patients are divided into the intervention and control groups according to the order of referral, using the supplemental block list by a physician in charge of the pharmacy. The intervention group will receive L-carnitine from the pharmacy according to the list.
Randomization method: Permutation block design or quadruple blocks will be used. We assign different permutations to numbers 1 to 6 in the following order.
1. AABB
2. ABAB
3. ABBA
4. BBAA
5. BABA
6. BAAB
Then, using the table of random numbers, we extract the numbers from the table and depending on which one of the numbers 1 to 6 comes, select each of the blocks assigned to these numbers until 19 blocks of 4 are selected. If the numbers are zero, 7, 8, and 9, we will ignore them and continue this order to provide a complete list for the entire sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
The medical students and a gastroenterologist will examine the patient and evaluate the laboratory tests, and frailty index under blinded conditions.
The data analyzer is also unaware of case and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
There is no spesific information.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Ethics Commitee, Shiraz University of Medical Sciences, Zand Street, Beside Helal Ahmar, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2022-01-05, 1400/10/15
Ethics committee reference number
IR.SUMS.MED.REC.1400.540
Health conditions studied
1
Description of health condition studied
liver cirrhosis
ICD-10 code
K74.60 - A
ICD-10 code description
K74- Fibrosis and cirrhosis of liver › 2022 ICD-10-CM Diagnosis Code K74.69.
Primary outcomes
1
Description
ّFraility
Timepoint
before intervention, after 2 months
Method of measurement
Liver frailty index. The liver frailty index will be used in the evaluation of frailty in patients with cirrhosis. This criterion consists of three parts. The Frilati Liver Index consists of three performance-based tests (grip strength, chair stands, and balance), a tool that measures physical function specifically in patients with cirrhosis.
Secondary outcomes
1
Description
Hepatic encephalopathy
Timepoint
Before intervention and 2, months after intervention
Method of measurement
Clinical examination, and lab data
2
Description
Creatinine level
Timepoint
before intervention, and 2 months after intervention
Method of measurement
lab data
Intervention groups
1
Description
The intervention group receives the L-carnitine supplement (b-hydroxy-gN-trimethylamino-butyric acid), an essential nutrient in the diet. The main function of L-carnitine in cellular energy metabolism, and as an essential element in the transfer of long-chain fatty acids to the inner mitochondrial membrane and the site of beta oxidation. The dose of L-carnitine 500 mg capsule orally three times a day for two months will be given to the patient along with the conventional medication regimen. British Life Plan manufacturer, importer of Nikan Pharmed Mehr Company
Category
Other
2
Description
Among patients who have the inclusion criteria and are willing to participate in the study, 35 patients are considered as a control group according to the block list. They will receive conventional medication regimens from pharmacies.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Transplant Research Center
Full name of responsible person
Nasrin Motazedian
Street address
Seventh floor, Transplant Research Center, Research Tower, Mollasadra St., Khalili Ave., Shiraz, IR Iran.
City
Shiraz
Province
Fars
Postal code
71867
Phone
+98 71 3628 1529
Email
motazediann@yahoo.com
Web page address
https://strc.sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shiraz Transplant Research Center
Street address
7th floor, Transplant Research Center,Mohammad Rasool Allah Reserch Tower,Khalili Ave., Shiraz.
City
Shiraz
Province
Fars
Postal code
7193635899
Phone
+98 71 3628 1529
Email
transrsh@sums.ac.ir
Web page address
https://strc.sums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz Transplant Research Center
Proportion provided by this source
80
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
Nasrin Motazedian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Seventh floor, Transplant Research Center, Mohammad Rasulallah Research Tower, Mollasadra St., Khalili Ave., Shiraz, IR Iran
City
Shiraz
Province
Fars
Postal code
7193635899
Phone
+98 71 3628 1529
Fax
Email
motazediann@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Motazedian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Community Medicine
Street address
Shiraz Transplant Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
0098716281529
Email
motazediann@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Nasrin Motazedian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
7th floor, Transplant Research Center,Mohammad Rasool Allah Reserch Tower,Khalili Ave., Shiraz.
City
Shiraz
Province
Fars
Postal code
7193635899
Phone
0098716281529
Email
motazediann@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD