Evaluation the effect of Modified Atkins diet in controlling refractory epilepsy in adult patients and comparing with adult epileptic patients without using this diet: a controlled randomized clinical trial
We will aim to conduct a controlled randomized clinical trial to evaluate the efficacy of modify Atkin diet in adult with refractory epilepsy between patinets using and not using modify Adkin diet. The inclusion criteria were the age of ≥18 years and refractory epilepsy (two or more seizures attacks every month in spite of treatment with at least two appropriate antiepileptic drugs). Adults with hypercholesterolemia, cardiovascular, or renal disease will exclude. Patients significantly underweight (body mass index < 18.5), with status epilepticus within the past 6 months, or nonepileptic seizures will also exclude from participation. We will enroll 60 refractory adult epileptic cases. time of intervention will be two months. The primary outcome will be at least 50% decrease in seizure frequency
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138803051949N1
Registration date:2013-02-09, 1391/11/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-09, 1391/11/21
Registrant information
Name
Mohammad Zare
Name of organization / entity
Isfahan University of Medical Sceinces
Country
Iran (Islamic Republic of)
Phone
+98 31 1227 9544
Email address
zare@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Science
Expected recruitment start date
2010-01-01, 1388/10/11
Expected recruitment end date
2012-12-31, 1391/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Modified Atkins diet in controlling refractory epilepsy in adult patients and comparing with adult epileptic patients without using this diet: a controlled randomized clinical trial
Public title
Comparison the effect of Modified Atkins diet in decreasing frequency of seizure in adult patients with refractory epilepsy with using Modified Atkins diet and patients with refractory epilepsy control without using Modified Atkins diet group.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
>18 years; taking at least two types of anticonvulsants; at least have monthly seizures.
Exclusion Criteria:
Adults with hypercholesterolemi, cardiovascular, renal disease; patients significantly underweight (body mass index < 18.5); status epilepticus within the past 6 months; nonepileptic seizures
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Postal code
Approval date
2009-01-20, 1387/11/01
Ethics committee reference number
388085
Health conditions studied
1
Description of health condition studied
epilepsy
ICD-10 code
G40
ICD-10 code description
Localization-related (focal)(partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset
Primary outcomes
1
Description
decrease of 50% number of seizure attack
Timepoint
In the first day and every 4 weeks till two months
Method of measurement
history
Secondary outcomes
1
Description
Increase of ketone body
Timepoint
weekly
Method of measurement
urinary dipstick
Intervention groups
1
Description
1- Case group: Modify Atkin's diet (Less than 15 gr carbohydrate/day in diet) for two months
Category
Lifestyle
2
Description
2- Control group: No diet
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr Ali Asghar Okhovat Souraki
Street address
Isfahan -soffe Ave-alzahra hospital
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Taleb Azarm
Street address
Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
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
Isfahan University of Medical Sciences
Full name of responsible person
Mohammad Zare
Position
Associate Proffesor of Neurology
Other areas of specialty/work
Street address
Al Zahra Hospital, Sofeh Street, Neurology section
City
Isfahan
Postal code
8174675731
Phone
+98 31 1625 5555
Fax
+98 31 1668 4510
Email
zare@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mohammad Zare
Position
Associate Proffesor of Neurology
Other areas of specialty/work
Street address
Al Zahra Hospital, Sofeh street, Neurology secton
City
Isfahan
Postal code
8174675731
Phone
+98 31 1625 5555
Fax
+98 31 1668 4510
Email
zare@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mohamad Zare
Position
Associated Proffesor of Neurology
Other areas of specialty/work
Street address
Alzahra hospital, Sofeh street, Neurology section
City
Isfahan
Postal code
8174675731
Phone
+98 31 1227 9544
Fax
+98 31 1668 4510
Email
zare@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)