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Assesment of ketogenic diet effects on lipid profile in patients with refractory epilepsy.

Protocol summary

Summary
In this study, patients suffering from refractory epilepsy are referred by Child Neurologists to Ketogenic Diet clinic. IN this clinic parents and patients,if possible, are provided with essential information and skills about side effects and advantages of this diet. Provided that testimonial was thoughtfully submitted by parents or caregivers, that they were privileged to treat their child by Ketogenic Diet, laboratory tests should be performed.If there is no contraindication in laboratory results,the patient will be admitted in the hospital to start Ketogenic Diet. The patients are being followed based on specific protocols.Follow-up evaluations include: lipid profiles, liver function tests, urine analysis, kidneys ultrasonography, and echocardiography in determined intervals. In this study, essential laboratory tests are conducted before admission, one month,three months and six months after starting treatment. If there is any critical side effect during treatment, Ketogenic Diet will be stopped promptly. At the end of six-month duration of study, data will be evaluated statistically.The type of regimen is classical and is not changed to other kinds of regimen such as Atkins( if so, the patient will be omitted from study). However our study is over in this stage, but treatment of patients will be observed continuously until the end.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015042021607N2
Registration date: 2015-07-04, 1394/04/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-07-04, 1394/04/13
Registrant information
Name
Parviz Karimi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6174
Email address
p-karimi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-01-11, 1393/10/21
Expected recruitment end date
2015-07-12, 1394/04/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assesment of ketogenic diet effects on lipid profile in patients with refractory epilepsy.
Public title
Assessment of ketogenic diet(KD) on blod lipid in patients with refractory epilepsy.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:refractory epilepsy ; don't have contraindicated ; Above 2 years old. Exclusion criteria: inability to continue the ketogenic diet for 6 months.
Age
From 2 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 33
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
In this study, patients suffering from refractory epilepsy are referred to Ketogenic Diet clinic. IN this clinic parents and patients,if possible, are provided with essential information and skills about side effects and advantages of this diet.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Keshavarz Blvd.
City
Tehran
Postal code
1417653761
Approval date
2015-01-10, 1393/10/20
Ethics committee reference number
9211118002-134395

Health conditions studied

1

Description of health condition studied
Refractory Epilepsy
ICD-10 code
G40-G47
ICD-10 code description
Episodic and paroxysmal disorders

Primary outcomes

1

Description
Plasma lipid profil
Timepoint
Before treatment and at three and six month after treatment
Method of measurement
TG; Total Chol; HDL; LDL by mg/dl

Secondary outcomes

1

Description
Effect of KD on seizure control; urin random Ca; Cr; oxalate; uric acid; BLOOD ca; vitD; thyroid function tests; liver function tests; heart failure
Timepoint
Before treatment; 3 mounths; 6 months after treatment
Method of measurement
Seizure control by reduction in numbers of paroxysms; urine random Ca; urine random uric acid urinerandom oxalate; liver function tests; thyroid function tests; serum Ca and vit D by mg/dl; cardiovascular by ejection fraction that measured by litre per min

Intervention groups

1

Description
In this study, patients suffering from refractory seizure are treated with classic KD. This type of treatment is continued according to the required response and tolerance .In Ketogenic Diet, 80 percent of calories are provided from fat and the rest from carbohydrates and proteins.Ketogenic diet has some complications. These complications include: nausea, vomiting, cinstipation, hyperlipidemia, renal stones, and heart failure. The risk of these complications has been not assessed adequately in Iran yet, so we evaluated patients in determined intervals.In this study,patients were followed clinically and by laboratory evaluations before and after treatment ,in tree months, six months, and 12months intervals
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Chidren's Medical Centr Hospital
Full name of responsible person
professor Mahmood Mohamadi
Street address
Chidren's Medical Centr Hospital, Dr. Gharib Street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Dr. Yunesian
Street address
Keshavarz Blvd
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Tehran 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
Chidren's Medical Centr Hospital
Full name of responsible person
Dr.Gholamreza Zamani
Position
Associated professor
Other areas of specialty/work
Street address
Chidren's Medical Centr Hospital, Dr. Gharib Street
City
Tehran
Postal code
1419733151
Phone
+98 21 6693 0068
Fax
Email
ghrzamani@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Chidren's Medical Centr Hospital
Full name of responsible person
Dr Maryam Mahmoodi
Position
Assistant Professor
Other areas of specialty/work
Street address
Chidren's Medical Centr Hospital, Dr. Gharib Street
City
Tehran
Postal code
1419733151
Phone
+98 21 6693 0068
Fax
Email
mahmoodi_mar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Parviz Karimi
Position
Fellow of Pediatric Neurology
Other areas of specialty/work
Street address
Chidren's Medical Centr Hospital, Dr. Gharib Street
City
Tehran
Postal code
1419733151
Phone
+98 21 6693 0068
Fax
Email
p-karimi@razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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