The effect of wheat germ oil on vitamin D levels and changes in liver enzymes in children 2 to 12 years old treated with phenobarbital and sodium valproate referred to Imam Ali Clinic in Shahrekord
Determining the effect of wheat germ oil on vitamin D levels and changes in liver enzymes in children 2 to 12 years old treated with phenobarbital and sodium valproate referred to Imam Ali Clinic in Shahrekord
Design
A total of 120 outpatients referred to a neurology clinic who have been diagnosed with epilepsy and meet the inclusion criteria are included in the study by simple random sampling and include two groups of 60 people consuming sodium valproate and phenobarbital. Each group is divided into two groups of 30 consumers and non-consumers of wheat germ oil. Thus, the four groups are studied as follows:
Group 1: Phenobarbital + Vitamin D + Wheat germ oil
Group 2: Phenobarbital + Vitamin D + Placebo
Group 3: Sodium valproate + Vitamin D + Wheat germ oil
Group 4: Sodium valproate + vitamin D + placebo
Settings and conduct
Single blind clinical trial. Vitamin D and liver enzymes of patients will be performed twice and with an interval of 3 months from the start of drug use and Also, children will receive the required daily prophylaxis amount of 400 units of vitamin D at the beginning of treatment, and each group consuming sodium valproate and phenobarbital is divided into two groups. One group treated with a soft capsule of one gram of wheat germ (three daily) In addition to vitamin D will be prophylaxis, and the other group in addition to vitamin D prophylaxis will be placebo completely similar to the soft capsule of wheat germ oil.
Participants/Inclusion and exclusion criteria
Children 2 to 12 years old treated with phenobarbital and sodium valproate
Intervention groups
Four groups are studied as follows:
Group 1: Phenobarbital + Vitamin D + Wheat germ oil
Group 2: Phenobarbital + Vitamin D + Placebo
Group 3: Sodium valproate + Vitamin D + Wheat germ oil
Group 4: Sodium valproate + vitamin D + placebo
Main outcome variables
Vitamin D levels
Liver enzyme levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210319050742N1
Registration date:2021-06-04, 1400/03/14
Registration timing:prospective
Last update:2021-06-04, 1400/03/14
Update count:0
Registration date
2021-06-04, 1400/03/14
Registrant information
Name
Samane Safari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3224 3716
Email address
st-safari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of wheat germ oil on vitamin D levels and changes in liver enzymes in children 2 to 12 years old treated with phenobarbital and sodium valproate referred to Imam Ali Clinic in Shahrekord
Public title
The effect of wheat germ oil on vitamin D levels and changes in liver enzymes in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of epilepsy
Has an age of 2 to 12 years
Lack of underlying disease that affects the metabolism of vitamin D and calcium
Do not take drugs or drugs that affect the metabolism of calcium and vitamin D.
Do not receive oral or injectable vitamin compounds containing vitamin D in the last 3 months.
Do not suffer from acute and chronic liver diseases
Do not have fatty liver
Do not take other drugs that affect the level of liver enzymes
Exclusion criteria:
Change in the definitive diagnosis of epilepsy
Existence of underlying diseases that affect the metabolism of vitamin D and calcium
Taking medication or drugs that affect calcium and vitamin D metabolism
Dissatisfaction of parents
Failure to follow instructions and perform tests
Changing the treatment protocol
Drug allergy
Physical disorder that hinders the patient's activity.
History of fracture
Vitamin D deficiency
Low calcium levels
Acute and chronic liver diseases
Taking other drugs with hepatic metabolism
Age
From 2 years old to 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is based on a table of random numbers and blocks of 4 and the study is done in double-blind.
Blinding (investigator's opinion)
Double blinded
Blinding description
Wheat germ oil and placebo have been coded to blind the product. The patient and the researcher are not aware of the type of drug administered.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Shahre-Kord University of Medical Sciences, Parastar Ave.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Approval date
2021-04-20, 1400/01/31
Ethics committee reference number
IR.SKUMS.REC.1400.040
Health conditions studied
1
Description of health condition studied
Children treated with phenobarbital and sodium valproate
ICD-10 code
G40
ICD-10 code description
Epilepsy and recurrent seizures
Primary outcomes
1
Description
Liver enzyme levels and vitamin D levels
Timepoint
In two rounds and with an interval of 3 months from the start of taking the drug
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Group 2: Phenobarbital + Vitamin D + Placebo
Category
Treatment - Drugs
2
Description
Intervention group: Group 1: Phenobarbital + Vitamin D + Wheat germ oil
Category
Treatment - Drugs
3
Description
Control group: Group 4: Sodium valproate + vitamin D + placebo
Category
Treatment - Drugs
4
Description
Intervention group: Group 3: Sodium valproate + Vitamin D + Wheat germ oil
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital, Shahrekord
Full name of responsible person
Anahita Farahzad
Street address
Parastar Aven
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
st-safari.s@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehraban Sadeghy
Street address
Shahre-Kord University of Medical Sciences, Parastar Ave.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
st-safari.s@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Samaneh Safari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Shahre-Kord University of Medical Sciences, Parastar Ave.
City
Sahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
st-safari.s@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Samaneh Safari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Shahre-Kord University of Medical Sciences, Parastar Ave.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
st-safari.s@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Samaneh Safari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Hajar Hospital, Parastar Ave.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816754633
Phone
+98 38 3222 0016
Email
st-safari.s@skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
No - There is not 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
Only part of the data such as information about the main outcome or the like can be shared.
When the data will become available and for how long
2021-2022
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
I have not decided yet
From where data/document is obtainable
I have not decided yet
What processes are involved for a request to access data/document