Study population are 333 patients with Epilepsy referred from Neurology Clinic of Imam Reza Hospital and Farabi Hospital to Gastroenterology Clinic. At first, patients will be screened for celiac with anti-tTG laboratory test and duodenal biopsy will be performed in positive test patients for final approval. They will be randomly divided into two groups. All of patients will be monitored continuously for 3 months and frequency and duration of seizures will be recorded. Group A (intervention) will receive a gluten-free diet to treat celiac disease and group B (control) will continue normal diet. Patients will be visited monthly till 5 months and frequency and duration of seizures will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108097271N1
Registration date:2011-09-01, 1390/06/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-09-01, 1390/06/10
Registrant information
Name
Nosratollah Babaii
Name of organization / entity
Kermanshah Univercity of Medical Scinces
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6302
Email address
nbabaii@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah univercity of medical scinces
Expected recruitment start date
2011-06-14, 1390/03/24
Expected recruitment end date
2012-12-14, 1391/09/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the prevalence of celiac in epilepsy patients and effect of gluten-free diet in controlling the seizureof the patients
Public title
Study of celiac frequency in epileptic patient and influnce of celiac treatment on treatment of epilepsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Epilepsy and getting experience at least one seizure per month during the past six months; confirmed celiac disease with a positive tTG test and duodenal biopsy. Exclusion criteria: Changing the type or dose of anticonvulsant drug in the study period.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
333
Randomization (investigator's opinion)
Randomized
Randomization description
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
Kermanshah university of medical sciences and health services
Street address
Kermanshah university of medical sciences and health services, Shahid beheshti Blvd
City
kermanshah
Postal code
6714858743
Approval date
2011-06-14, 1390/03/24
Ethics committee reference number
12533
Health conditions studied
1
Description of health condition studied
epilepsy
ICD-10 code
G40
ICD-10 code description
epilepsy
2
Description of health condition studied
celiac
ICD-10 code
K90.0
ICD-10 code description
Coeliac disease
Primary outcomes
1
Description
seizure
Timepoint
monthly till 5 month after begining of intervention
Method of measurement
seizures frequency and duration of each seizure
Secondary outcomes
empty
Intervention groups
1
Description
control group: no intervention
Category
N/A
2
Description
intervention group: gluten-free diet
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology Clinic of Imam Reza Hospital and Farabi Hospital Kermanshah.
Full name of responsible person
Dr Nosratollah Babai
Street address
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah university of medical sciences and health services
Full name of responsible person
Dr Fraid Njafi
Street address
Kermanshah university of medical sciences and health services, Shahid beheshti Blvd
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah university of medical sciences and health services
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
Name of organization / entity
Kermanshah university of medical sciences and health services.
Full name of responsible person
Dr Nosratollah Babai
Position
Resident f inernal medicine
Other areas of specialty/work
Street address
Internal medicine department, Imam Reza Hospital, Bagh-Abrisham Blvd
City
Kermanshah
Postal code
Phone
+98 83142763029
Fax
Email
nbabaii@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah university of medical sciences and health services
Full name of responsible person
Dr Nosratollah Babai
Position
Resident of Internal medicine
Other areas of specialty/work
Street address
Internal medicine departmet of Imam Reza Hospital, Bagh-Abrisham Blvd
City
Kermanshah
Postal code
Phone
+98 83142763029
Fax
Email
nbabaii@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah university of medical sciences and health services.
Full name of responsible person
Dr Nosratollah Babai
Position
Resident of Internal medicine
Other areas of specialty/work
Street address
Internal medicine of Imam Reza Hospital
City
Kermanshah
Postal code
Phone
+98 83142763029
Fax
Email
nbabaii@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)