Febrile seizure (FS) is the most common type of childhood seizures which occurs in 2-5% of children. Based on some other studies, zinc level in children with febrile seizure is lower than in children without seizure. The purpose of this study is to evaluate efficacy of zinc sulfate on FS recurrence during the year after first simple FS.
A randomized, clinical trial, will be conducted on 100 children aged 18-60 months with first simple FS and normal zinc level ( more than 70µg/dL ) whom will be admitted to Shahid Sadoughi Hospital , Yazd, Iran.
The children will be distributed into two groups. In group one , 50 children will receive 2mg/kg/day zinc sulfate orally for six months and in the second group as control group , they will receive a placebo . Then , they will be followed up every three months for one year for the recurrence of febrile seizure , timing of recurrence and side effects .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201211262639N9
Registration date:2012-12-06, 1391/09/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-06, 1391/09/16
Registrant information
Name
Razieh Fallah
Name of organization / entity
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 4000
Email address
fallah@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Shahid Sadoughi University of Medical Sciences , Yazd, Iran .
Expected recruitment start date
2012-03-28, 1391/01/09
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of zinc sulfate on seizure recurrence during one year after first simple febrile seizure
Public title
Effect of zinc sulfate on recurrence of febrile seizure
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria :
1. Aged 18-60 months
2. With first simple febrile seizure
3. Weight and height more than 3 percentile
4. Normal hemoglobin level and MCV
5. Not receiving a zinc combinations within the past one month
6. Normal zinc level
Exclusion criteria:
1. presence of any serious systemic diseases(cardiac, renal, metabolic , malignancy or rheumatologic )
2. History of previous afebrile seizure
3. with neurodevelopmental delay or mental retardation
4. with acute CNS infection : meningitis , encephalitis
Age
From 1 year old to 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Street address
Bahonar Square, Central Building of University
City
Yazd
Postal code
Approval date
2012-11-21, 1391/09/01
Ethics committee reference number
119121
Health conditions studied
1
Description of health condition studied
Febrile convulsions
ICD-10 code
R56.0
ICD-10 code description
Febrile convulsions
Primary outcomes
1
Description
recurrence of febrile seizure
Timepoint
every three months for one year
Method of measurement
Taking history and physical examination
2
Description
timing of recurrence of febrile seizure
Timepoint
every three months for one year
Method of measurement
Taking history and physical examination
Secondary outcomes
1
Description
side effects
Timepoint
every three months for one year
Method of measurement
Taking history and physical examination
Intervention groups
1
Description
2mg/kg/day zinc sulfate orally for six months
Category
Treatment - Drugs
2
Description
a placebo in control group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Razieh Fallah MD
Street address
Ave sina St, Shahid Ghandi Blvd,
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Shahid Sadoughi University of Medical Sciences , Yazd, Iran .
Full name of responsible person
Dr.Fatemah Ezoddini
Street address
Bahonar Square, Central Building of University
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Shahid Sadoughi University of Medical Sciences , Yazd, Iran .
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences , Yazd , Iran
Full name of responsible person
Razieh Fallah
Position
Pediatric Neurologist , Associate professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital, Ave sina St, Shahid Ghandi Blvd
City
Yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
FALLAH@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)