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

Refractory Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03031028
• Other study ID #: 94-03-161-30342
• Status: Recruiting
• Phase: Phase 2
• First received: December 31, 2016
• Last updated: January 21, 2017
• Start date: July 2016
• Est. completion date: March 2017

Study information

• Verified date: September 2016
• Source: Tehran University of Medical Sciences
• Contact: Maryam Mahmoudi, MD, PHD
• Phone: 00989126182883
• Email: m-mahmoudi[@]sina.tums.ac.ir
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Refractory Epilepsy

Intervention

Other:
• ketogenic diet
Ketogenic Diet is a high fat, low carbohydrate diet.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran university of medical science, school of nutritional science and dietetics	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	seizure rate	The information will be obtained through seizure diary	3 months
Secondary	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.
Secondary	Investigating side effects	Side effects will be obtained via parents' reports.	After 3 months on the classical KD
Secondary	serum Triglyceride	serum Triglyceride will be assessed. Units for serum TG, is mg/dl.	Before and after 3 months on the classical KD
Secondary	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.
Secondary	serum Cholesterol,	serum Cholesterol will be assessed. Units for serum Cholesterol is mg/dL.	Before and after 3 months on the classical KD
Secondary	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.
Secondary	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