Comparison of the effectiveness of two different doses of ferrous sulfate on recurrence rate, one year after the first febrile convulsion(FC) in children one to five years old without iron deficiency anemia
Comparison of the effectiveness of two different doses of ferrous sulfate on the frequency distribution of recurrence within one year after the first febrile convulsion
Design
Clinical trial with parallel,double-blind,randomized,phase 2 in 100 patients.A random number table was used for randomization.
Settings and conduct
Children one to five years old, who have been hospitalized in the pediatric ward of Shahid Sadoughi Hospital in Yazd since June 1400 due to the first febrile convulsion; After obtaining the parents' consent, they enter the study.
They are then randomly divided into two groups to prescribe two different doses of ferrous sulfate syrup and followed up every three months for one year. A pediatric resident who evaluates the outcome and the participants are kept blind to the study groups.
Participants/Inclusion and exclusion criteria
Login:The age of the child should be in the range of 12 to 60 months,The first febrile convulsion,Hemoglobin levels and mean red blood cell volume are in the normal range.No entry:Developmental delay,History of seizures without previous fever,Serious systemic disease,History of intolerable side effects of oral iron.
Intervention groups
Pediatrics one to five years old with the first seizure of febrile convulsion,One group iron sulfate one milligram per kilogram of body weight and the other group of iron sulfate three milligram per kilogram of body weight for one year is prescribed.Iron sulfate syrup per The two groups are similar and from the same manufacturer.
Main outcome variables
Recurrence of febrile convulsion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200728048243N1
Registration date:2021-05-27, 1400/03/06
Registration timing:registered_while_recruiting
Last update:2021-05-27, 1400/03/06
Update count:0
Registration date
2021-05-27, 1400/03/06
Registrant information
Name
Saeed Zakerzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3628 4379
Email address
s.zakerzadeh@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-26, 1400/03/05
Expected recruitment end date
2021-09-27, 1400/07/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of two different doses of ferrous sulfate on recurrence rate, one year after the first febrile convulsion(FC) in children one to five years old without iron deficiency anemia
Public title
Evaluation of the effectiveness of ferrous sulfate in preventing recurrence of febrile convulsion
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The Age of the Child should be in the Range of 12 to 60 Months
With first febrile convulsion
Normal hemoglobin level and mean corpuscular volume(MCV)
Exclusion criteria:
The Patient has Mental Retardation or Developmental Delay
The Patient has a history of previous afebrile seizure
Existence of Serious Systemic Disease in the Patient(Heart,Liver,Renal Dysfunction ,Rheumatology Disease,Peptic Ulcer,IBD)
with acute CNS infection : meningitis , encephalitis
Age
From 12 months old to 60 months old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization, individual, table of random numbers,
Blinding (investigator's opinion)
Double blinded
Blinding description
The children studied are randomly selected and the therapeutic dose is selected using a random number table. To blind the study, after randomly selecting the samples, the dose of the drug in each group is calculated and prescribed by a pediatrician.The assessor is a pediatric resident and is unaware of the type of group selected and the dose of medication. Participants also become blind to study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences
Street address
Central Administration, Bahonar Sq
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2019-11-11, 1398/08/20
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.194
Health conditions studied
1
Description of health condition studied
febrile convulsion
ICD-10 code
R56.0
ICD-10 code description
Febrile convulsions
Primary outcomes
1
Description
Repeated febrile seizures
Timepoint
One year
Method of measurement
observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: receiving ferrous sulfate drops of 1 mg / kg
Category
Prevention
2
Description
Intervention group 2: receiving ferrous sulfate drops of 3 mg / kg
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Shahid sadoughi hospital
Full name of responsible person
Zakerzadeh Forushani saeed
Street address
Shahid Ghandi Blvd, Safaieh
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3822 4000
Email
sshipd67@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mirzayi Masoud
Street address
Central Administration, Bahonar Sq,Yazd University
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3725 8410
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Saeed Zakerzadeh
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No.15, Alley 19, Chamran St.
City
Yazd
Province
Yazd
Postal code
8915743194
Phone
+98 35 3628 4379
Fax
Email
s.zakerzadeh@stu.ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Nafei Zahra
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Central Administration,Bahonar Sq,Yazd University
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3725 8410
Email
z.nafeie@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Saeed Zakerzadeh
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No.15, Alley 19, Chamran St.
City
Yazd
Province
Yazd
Postal code
8915743194
Phone
+98 35 3628 4379
Fax
Email
s.zakerzadeh@stu.ssu.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Only data on age, sex, medication dose, and main outcome (recurrence of febrile seizures) will be shared.
When the data will become available and for how long
Access starts 6 months after the results are published
To whom data/document is available
Researchers working in medical universities
Under which criteria data/document could be used
Data requested by other researchers for comparison with similar studies.
From where data/document is obtainable
Zahra Nafei
email adress: z.nafeie@ssu.ac.ir
What processes are involved for a request to access data/document
If you need to receive the data, send a message via email so that after the review, it will be provided to the applicant within a maximum period of one month.