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

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

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.

Study Overview

• Status: Unknown
• Conditions: Refractory Epilepsy
• Intervention / Treatment: Other: 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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Recruiting
    • Tehran university of medical science, school of nutritional science and dietetics
    • Contact: Maryam Mahmoudi, MD,PHD; Phone Number: 00989126182883; Email: m-mahmoudi@sina.tums.ac.ir
    • Principal Investigator: Mona Kavoosi, MSc student

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
seizure rate	The information will be obtained through seizure diary	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences
• Investigators: Study Director: Maryam Mahmoudi, MD, PHD, Tehran university of medical science, school of nutritional science and dietetics

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (ANTICIPATED): February 1, 2017
• Study Completion (ANTICIPATED): March 1, 2017

Study Registration Dates

• First Submitted: December 31, 2016
• First Submitted That Met QC Criteria: January 21, 2017
• First Posted (ESTIMATE): January 25, 2017

Study Record Updates

• Last Update Posted (ESTIMATE): January 25, 2017
• Last Update Submitted That Met QC Criteria: January 21, 2017
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: epilepsy; efficacy; ketogenic diet; refractory epilepsy,; classic ketogenic diet; seizure rate
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Drug Resistant Epilepsy
• Other Study ID Numbers: 94-03-161-30342

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED