Determination of the effect of astaxanthin on cytokeratin 18 levels and liver enzymes
Design
A concealed, randomized, blinded, controlled clinical trial with a parallel group
Settings and conduct
Patients with non-alcoholic fatty liver referred to clinics affiliated to Isfahan University of Medical Sciences are divided into control and intervention groups. Astaxanthin tablets are given to the intervention group and a placebo is given to the control group. Patients, physicians, researchers, and drug distributors do not know which patient will given the drug or placebo
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Children with non alcoholic fatty liver 2- Age 5-15 years old 3-Liver enzyme elevation excess than 40 unit/lit and diagnosis of fatty liver in sonography. •Exclusion criteria: 1-Viral Hepatitis or auto immune, Diabetes, Hemochromatosis, Cirrhosis, infectious disease, hypothiroidism 2-Consumption of drugs that effect on liver enzyme during last two months 3-Alcohol consumption 4-Discontinuing the study by the patient or his/her family
Intervention groups
Intervention group:8 to 18 years old children with non-alcoholic fatty liver who will be received astaxanthin. Control group: 8 to 18 years old children with non-alcoholic fatty liver who received placebo.
The effect of astaxanthin supplementation on cytokeratin 18 levels in children and adolescents with non-alcoholic fatty liver
Public title
The effect of astaxanthin supplementation on cytokeratin 18 levels
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with non- alcoholic fatty liver disease
Age between 8-18 years old
Elevation of liver enzyme more than 40 Unit/Litre
Evidence of fatty liver in sonography
Exclusion criteria:
Diagnosis of liver disease other than NAFLD such as : Viral hepatitis,Autoimmune hepatitis, Diabetes, Hemochromatosis, Cirrhosis, Infectious disease, Hypothyroidism
Consumption of drugs that effect on liver enzyme during last two months
Alcohol consumption
Discontinuing the study by the patient or his/her family
Age
From 8 years old to 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:
58
Randomization (investigator's opinion)
Randomized
Randomization description
During random allocation, patients will be divided into two groups of interventional and placebo by permutation block method with blocks of volume 4. (Possible permutations are: AABB, ABAB, ABBA, BBAA, BABA, BAAB). Using the random permutation block method, the samples will be assigned to two groups. Random sequences are generated using R software and a randomizeR software package
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this research, patient, researcher and data analyser not know which patient receives the drug and which one receives a placebo
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee ofIsfahan medical university
Street address
Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-04-06, 1400/01/17
Ethics committee reference number
IR.MUI.MED.REC.1400.005
Health conditions studied
1
Description of health condition studied
Non alcoholic fatty liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
serum level of Alanine aminotransferase
Timepoint
Eight weeks after treatment initiation with placebo and astaxanthin
Method of measurement
Quantitative measurement of liver transaminase
2
Description
serum level of Aspartate aminotransferase
Timepoint
Eight weeks after treatment initiation with placebo and astaxanthin
Method of measurement
Quantitative measurement of liver transaminase
3
Description
Serum levels of cytokeratin 18
Timepoint
Eight weeks after treatment initiation with placebo and astaxanthin
Method of measurement
Eliza method
Secondary outcomes
1
Description
Body fat mass
Timepoint
Eight weeks after treatment initiation with placebo and astaxanthin
Method of measurement
Inbody 270 body composition measuring device
2
Description
Lean body mass
Timepoint
Eight weeks after treatment initiation with placebo and astaxanthin
Method of measurement
Inbody 270 body composition measuring device
3
Description
Body mass index
Timepoint
Eight weeks after treatment initiation with placebo and astaxanthin
Method of measurement
Measurement of height and weight and ratio of weight to square of height
4
Description
Waist circumference
Timepoint
Eight weeks after treatment initiation with placebo and astaxanthin
Method of measurement
Measurement with meters
5
Description
Hip circumference
Timepoint
Eight weeks after treatment initiation with placebo and astaxanthin
Method of measurement
Measurement with meters
6
Description
Weight
Timepoint
Eight weeks after treatment initiation with placebo and astaxanthin
Method of measurement
Measurement with scales
7
Description
Height
Timepoint
Eight weeks after treatment initiation with placebo and astaxanthin
Method of measurement
Measurement with meters
Intervention groups
1
Description
Control group: The placebo will be taken once a day with lunch, which is quite similar in color and size to the main medicine
Category
Placebo
2
Description
Intervention group: Patients in the astaxanthin group will receive one 8 mg tablet containing astaxanthin daily with lunch for 8 weeks. Astaxanthin supplement is provided by Nature Vision company in USA. This supplement was made from the alga Haematococcus pluvialis.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics affiliated to Isfahan University of Medical Sciences
Full name of responsible person
Majid Khademian
Street address
Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3386 8247
Email
khademian51@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Majid Khademian
Street address
Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3386 8247
Email
khademian51@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Esfahan University of Medical science
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
Esfahan University of Medical Sciences
Full name of responsible person
Majid Khademian
Position
Faculty member
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3386 8247
Email
khademian51@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Majid Khademian
Position
Faculty member
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3386 8247
Email
khademian51@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Motahar Heidari-Beni
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar Jerib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5284
Email
heidari.motahar@gmail.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
After the implementation of the research, the results will be available to the scientific community.
When the data will become available and for how long
One Year after publication
To whom data/document is available
Professional Researchers in this field
Under which criteria data/document could be used
After communication with the corresponding author of the project, the researchers in this field can access some statistical analysis file information
From where data/document is obtainable
Principal Investigator Dr. Majid Khademian Isfahan University of Medical Sciences, Faculty of Medicine, Pediatric Department of Gastroenterology, khademian51@yahoo.com
What processes are involved for a request to access data/document
After E-Mail to the corresponding author of the project, they will be able to provide the documentation to them. khademian51@yahoo.com