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

NCT ID: NCT03031028

Last Updated: 2017-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-03-31

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.

Conditions

Refractory Epilepsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ketogenic diet

Ketogenic diet

Group Type: OTHER

ketogenic diet

Intervention Type: OTHER

Ketogenic Diet is a high fat, low carbohydrate diet.

Interventions

ketogenic diet

Ketogenic Diet is a high fat, low carbohydrate diet.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tehran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maryam Mahmoudi, MD, PHD

Role: STUDY_DIRECTOR

Tehran university of medical science, school of Nutritional science and Dietetics

Locations

Tehran university of medical science, school of nutritional science and dietetics

Tehran, Tehran Province, Iran

Site Status: RECRUITING

Countries

Iran

Central Contacts

Maryam Mahmoudi, MD, PHD

Role: CONTACT

m-mahmoudi@sina.tums.ac.ir

00989126182883

Mona Kavoosi, MSc student

Role: CONTACT

m_kavoosi@razi.tums.ac.ir

00989123759711

Facility Contacts

Maryam Mahmoudi, MD,PHD

Role: primary

m-mahmoudi@sina.tums.ac.ir

00989126182883

Other Identifiers

94-03-161-30342

Identifier Type: -

Identifier Source: org_study_id