Comparison of the effects and side effects of fenofibrate and omega-3 in children with hypertriglyceridemia
Design
The clinical trial has two intervention groups, with parallel groups, one-blind, randomized, on 60 patients, and SAS version 9 software is used for randomization with the method of 4 permutation blocks.
Settings and conduct
The study will be conducted in Rasht 17 Shahrivar hospital (endocrine department) in two intervention groups 1 and 2. The patients are not blind to the treatment group and are only researchers and statistics experts analyzing the information blind to the treatment group
Participants/Inclusion and exclusion criteria
Inclusion criteria: children 8 to 18 years old
Higher triglyceride equal to 400mg/dl
Lack of pregnancy, acute or chronic pancreatitis, acute hepatitis, sepsis
No alcohol consumption
Absence of liver, kidney and biliary diseases
Also, children with total cholesterol higher than 200 mg/dl or LDL higher than 130 mg/dl who are being treated with statins or ezetimibe will not be included
Intervention groups
The first group receives fenofibrate 100 mg once a day along with diet and the second group receives 1000 mg omega-3 twice a day. The duration of the intervention is 12 weeks and all patients are monitored weekly and monthly by pediatric endocrinologists.
Main outcome variables
Fasting blood triglyceride
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220516054879N4
Registration date:2023-01-21, 1401/11/01
Registration timing:registered_while_recruiting
Last update:2023-01-21, 1401/11/01
Update count:0
Registration date
2023-01-21, 1401/11/01
Registrant information
Name
maryam shahrokhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3336 9026
Email address
mshahrokhi@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An efficacy and safety comparison study of Fenofibrate and omega 3 in pediatric patients with Hypertriglyceridemia, A Randomized Clinical Trial
Public title
An efficacy and safety comparison study of Fenofibrate and omega 3 in pediatric patients with Hypertriglyceridemia, A Randomized Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
8-12 years old Patients with hypertriglyceridemia, with triglyceride more than 400mg/dl or triglyceride more than 250mg/dl that are intended to use medication or not responded to diet and exercise.
Exclusion criteria:
Patient reluctance
Patient treated with statins or ezetimibe
Pragnancy
Acute or chronic pancreatitis
Age
From 8 years old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Type of randomization, details of any restrictions (such as blocking and block size):
To randomize people in two groups, permutation blocks (of 4) are used. Considering that group A is the recipient of fenofibrate and group B is the recipient of omega-3. The randomization process will be as follows. The entire randomization file is available as an Excel file (randomization was done with SAS software version 9).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Gilan University of Medical Sciences
Street address
Rasht-Namjo Street-Shahid Siadati Street-in front of 17 Shahrivar Hospital-Deputy for Research and Technology
City
Rasht
Province
Guilan
Postal code
4193713111
Approval date
2022-12-21, 1401/09/30
Ethics committee reference number
IR.GUMS.REC.1401.483
Health conditions studied
1
Description of health condition studied
Hypertriglyceridemia
ICD-10 code
E78.1
ICD-10 code description
Pure hyperglyceridemia, Endogenous hyperglyceridemia
Primary outcomes
1
Description
Fasting blood triglycerides
Timepoint
The variable will be measured at the beginning of the study, 8 and 12 weeks after the start of the study
Method of measurement
Blood tests
2
Description
Fasting blood LDL level
Timepoint
The variable will be measured at the beginning of the study, 8 and 12 weeks after the start of the study.
Method of measurement
Blood tests
3
Description
Fasting blood cholesterol
Timepoint
The variable will be measured at the beginning of the study, 8 and 12 weeks after the start of the study
Method of measurement
Blood tests
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group : In addition to following the diet, they also receive fenofibrate 100 mg once a day after lunch for 12 weeks.
Category
Treatment - Drugs
2
Description
Intervention group: In addition to following the diet, they also receive 1000 mg of omega-3 twice a day for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان 17 شهریور
Full name of responsible person
مریم شاهرخی
Street address
Rasht - Namjo Street - Shahid Siyadati Street - 17 Shahrivar Hospital
City
Rasht
Province
Guilan
Postal code
4144654379
Phone
+98 13 3336 9019
Email
Mshahrokhi@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammadreza Naghipour
Street address
Rasht - Namjo Street - Shahid Siyadati Street - in front of 17 Shahrivar Hospita
City
Rasht
Province
Guilan
Postal code
4193713111
Phone
+98 13 3333 6394
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Maryam Shahrokhi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical pharmacy
Street address
Rasht - Namjo Street - Shahid Siyadati Street - 17 Shahrivar Hospital
City
Rasht
Province
Guilan
Postal code
414465379
Phone
0098133369019
Email
shahrokhi.mail85@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Maryam Shahrokhi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Rasht - Namjo Street - Shahid Siyadati Street - 17 Shahrivar Hospital
City
Rasht
Province
Guilan
Postal code
4144654379
Phone
+98 13 3336 9019
Email
shahrokhi.mail85@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Parnian Nemati
Position
Pharmacy student
Latest degree
Medical doctor
Other areas of specialty/work
Medical pharmacy
Street address
Rasht-Gaz Square- Emadieh Alley- No13
City
Rasht
Province
Guilan
Postal code
4145695715
Phone
+98 919 872 6386
Email
parnianne75@gmail.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
Preservation of patients' privacy and compliance with ethical principles
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
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The results of the study will be available to everyone. Exclusive information will be available only to the treatment staff. To respect the privacy of the patient, the patient's information will be kept by the researcher.
When the data will become available and for how long
Currently, there is no plan to publish the data, but if it is published, it will be 6 months after the results are published.
To whom data/document is available
Researchers who are active in this field, pediatric specialists and scientific and qualified people
Under which criteria data/document could be used
Doctors and researchers will have the right to request, there are restrictions in order to protect the patient's privacy and comply with medical ethics
From where data/document is obtainable
17 Shahrivar Hospital, Rasht - Dr. Maryam Shahrokhi, Faculty of Pharmacy, Gilan Medical Sciences - Parnian Nemati
What processes are involved for a request to access data/document
Go to 17 Shahrivar Hospital in Rasht and sign the application form, then meet with the researcher of the plan and review the application of the referring person, consult with the ethics committee in medicine and then submit the documents.