Effect of Outpatient Classic Ketogenic Diet in Epileptic Children and Adolescent.

Sponsor

Tehran University of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT03031028

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will consider the effectiveness of the ketogenic diet (high-fat, low-carbohydrate, and moderate protein) in treating epilepsy. Investigators enroll a group of eligible epileptic children and adolescent who have been referred from epilepsy center to our clinic and prescribe them ketogenic diet.

Condition or Disease	Intervention/Treatment	Phase
Refractory Epilepsy	Other: ketogenic diet	Phase 2

Detailed Description

This research will be done to observe efficacy, safety, and tolerability of the classic ketogenic diet (CKD) on an outpatient basis without fasting, caloric and fluid restriction in children with and adolescents with intractable epilepsy.

30 children and adolescents with intractable epilepsy based on inclusion and exclusion criteria have been enrolled in the study, Investigators prescribe them classic ketogenic diet. Efficacy of the diet will be assessed through seizure rates, number of anti-epileptic drug used by the patients, and EEG changes. Seizure frequency will be assessed by seizure record diary that is filled out by family of the patients and will be compared with data that will be taken at 1, 3 months after start of the diet. EEG will be taken at baseline and 3 months after start of the diet. Patients will be reviewed at 1, 3 months after start of the diet at outpatient clinic. Intolerances and Complications will be documented at each clinic visits and via telephone calling during clinic visits intervals to evaluate tolerability and safety of the KD. For close monitoring of the complications along with blood tests and urinalysis Investigators will do echocardiography and renal ultrasound at baseline and 3 months after start of the diet. Laboratory values will be assessed at baseline and 3 months after start of the diet. Also, nutritional status and growth of children will be assessed at baseline and 1, 3 months after start of diet.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Study of Outpatient Ketogenic Diet on Seizure Rate, Nutritional Status and Some Biochemical Factors in Children and Adolescent With Refractory Epilepsy.

Study Start Date :

Jul 1, 2016

Anticipated Primary Completion Date :

Feb 1, 2017

Anticipated Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: ketogenic diet Ketogenic diet	Other: ketogenic diet Ketogenic Diet is a high fat, low carbohydrate diet.

Arm

Intervention/Treatment

Other: ketogenic diet

Ketogenic diet

Other: ketogenic diet

Ketogenic Diet is a high fat, low carbohydrate diet.

Outcome Measures

Primary Outcome Measures

seizure rate [3 months]
The information will be obtained through seizure diary

Secondary Outcome Measures

Height [Before and after 1 and 3 months on the classical KD.]
Height of the participants will be assessed by stadiometer and Unit for height is cm.
Investigating side effects [After 3 months on the classical KD]
Side effects will be obtained via parents' reports.
serum Triglyceride [Before and after 3 months on the classical KD]
serum Triglyceride will be assessed. Units for serum TG, is mg/dl.
Weight [Before and after 1 and 3 months on the classical KD.]
Weight of the participants will be assessed by seca scale and Unit for weight is kilogram.
serum Cholesterol, [Before and after 3 months on the classical KD]
serum Cholesterol will be assessed. Units for serum Cholesterol is mg/dL.
serum LDL-Cholesterol [Before and after 3 months on the classical KD.]
serum LDL-Cholesterol will be assessed. Units for serum LDL-C is mg/dL.
serum HDL-Cholesterol [Before and after 3 months on the classical KD]
serum HDL-Cholesterol will be assessed. Units for serum HDL-C is mg/dL

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Ages 1-18 years,
The patient has tried at least 3 different AED:s including one combination with two or more different AED:s.
The parents are willing to include their child in the study after written and verbal information.
Patients with all types of epilepsy can be included.
The patient is submitted to our epilepsy center.

Exclusion Criteria:

The patient has a medical condition, for example a metabolic disease, where ketogenic diet is contraindicated.
The patient's nutritional status is not good enough or intake of fluid is to small to permit treatment with ketogenic diet.
No history of hyperlipidemia
No history of renal stones
No previous treatment with ketogenic diet
Beta-oxidation defects - medium-chain acyl dehydrogenase deficiency (MCAD), long-chain acyl dehydrogenase deficiency (LCAD), short-chain acyld dehydrogenase deficiency (SCAD), long-chain 3-hydroxyacyl-coenzyme A (CoA) deficiency, and medium-chain 3- hydroxyacyl-CoA deficiency.
The family is expected to have compliance problems with treatment and/or seizure registration