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

Phase 2

• Conditions: Refractory Epilepsy
• Interventions: Other: ketogenic diet

• Registration Number: NCT03031028
• Lead Sponsor: Tehran University of Medical Sciences

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.

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 Timeline

• Study Start: 2016-07
• Status Verified: 2016-09
• Study First Submitted: 2016-12-31
• Study First Submitted QC: 2017-01-21
• Last Update Submitted: 2017-01-21
• Study First Posted: 2017-01-25
• Last Update Posted: 2017-01-25
• Primary Completion: 2017-02
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ketogenic diet	ketogenic diet	Ketogenic diet

Primary Outcome Measures

Name	Time	Method
seizure rate	3 months	The information will be obtained through seizure diary

Secondary Outcome Measures

Name	Time	Method
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.
serum Triglyceride	Before and after 3 months on the classical KD	serum Triglyceride will be assessed. Units for serum TG, is mg/dl.
Investigating side effects	After 3 months on the classical KD	Side effects will be obtained via parents' reports.
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

Trial Locations

Locations (1)

Tehran university of medical science, school of nutritional science and dietetics; 🇮🇷 Tehran, Iran, Islamic Republic of