The effect of curcumin-piperine supplementation on inflammatory and oxidative stress factors, sonographic findings and symptom of depression, anxiety and stress in children with nonalcoholic fatty liver disease
The effect of curcumin-piperine supplementation on inflammatory and oxidative stress factors, sonographic findings and symptom of depression, anxiety and stress in children with nonalcoholic fatty liver disease.
Design
Randomized clinical trial, double-blind, randomized control group of 60 patients. Randomization is done using a valid website and 4-block method.
Settings and conduct
This study will be performed in Imam Hossein children's Hospital, Isfahan. The researchers, participants will be unaware of assigned treatments.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children with non alcoholic fatty liver, Age 10-18 years old
Exclusion criteria: Presence of hepatitis, Chronic liver disease , Cardiovascular, Renal, Pulmonary, Hypothyroidism diseases and cancer, Not consuming drugs that could affect on Alanine aminotransferase level including HMG-COA reductase inhibitors, metformin
Intervention groups
Intervention group: Capsules containing curcumin- piperine each containing 500 mg of curcumin and 5 mg of piperine once a day. Control group one capsule each containing 500 mg of maltodextrin
Main outcome variables
Inflammatory and oxidative stress factors, Sonographic findings
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20121216011763N54
Registration date:2022-03-28, 1401/01/08
Registration timing:registered_while_recruiting
Last update:2022-03-28, 1401/01/08
Update count:0
Registration date
2022-03-28, 1401/01/08
Registrant information
Name
Gholamreza Askari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2110
Email address
askari@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-12, 1400/12/21
Expected recruitment end date
2022-09-06, 1401/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of curcumin-piperine supplementation on inflammatory and oxidative stress factors, sonographic findings and symptom of depression, anxiety and stress in children with nonalcoholic fatty liver disease
Public title
Curcumin-piperine supplementation in children with none- alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with non alcoholic fatty liver disease
Age 10-18 years old
Exclusion criteria:
Presence of hepatitis, Chronic liver disease , Cardiovascular, Renal, Pulmonary, Hypothyroidism diseases and cancer
Not consuming drugs that could affect on Alanine aminotransferase level including HMG-COA reductase inhibitors, metformin
Age
From 10 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be divided into intervention and control groups using block classified randomization. The following authoritative site will be used to allocate the intervention in the above-mentioned manner.
https://www.sealedenvelope.com/simple-randomiser/v1/lists
In this way, people are randomly divided into two groups of intervention and control using quadruple blocks based on age and sex.
It is noteworthy that participants and outcome assessors will not be aware of patient grouping and will be blind to it.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, children will not be aware of received intervention. Furthermore, before the beginng of intervention, curcumin supplements and their placebo which are completely similar to each other, will be coded to A and B by a third person rather than main researcher to keep blindness of study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Vice-Chancellor in Research Affairs -Medical University of Isfahan
Street address
School of Nutrition and Food Sciences, Isfahan University of Medical Sciences, Hezar-jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-09-05, 1400/06/14
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.476
Health conditions studied
1
Description of health condition studied
None- alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
C-reactive protein
Timepoint
At the beginning of study - week 10
Method of measurement
Biochemical assessment
2
Description
Total antioxidant capacity
Timepoint
At the beginning of study - week 10
Method of measurement
Biochemical assessment
3
Description
Total oxidant status
Timepoint
At the beginning of study - week 10
Method of measurement
Biochemical assessment
4
Description
Oxidative stress index
Timepoint
At the beginning of study - week 10
Method of measurement
Biochemical assessment
Secondary outcomes
1
Description
Sonographic findings
Timepoint
At the beginning of study - week 10
Method of measurement
Liver ultrasonography
Intervention groups
1
Description
Intervention group: Take one capsule containing curcumin piperine daily (containing 500 mg curcumin extract and 5 mg piperine, Sami labs Ltd., India ) for 10 weeks.
Category
Treatment - Drugs
2
Description
Control group: They will receive one placebo capsule (500 mg of maltodextrin, Sami labs Ltd., India ) daily for 10 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein children's Hospital
Full name of responsible person
Mohaddese Abdi
Street address
Imam Khomeini Street - before Esteghlal Square
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Email
m.abdi4015@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Behruz Ataei
Street address
Hezar-jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 21 8145 5618
Email
ethics@behdasht.gov.ir
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 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
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar-jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3171
Email
askari@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar-jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3171
Email
askari@mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Hezar-jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3171
Email
askari@mui.ac.ir
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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