Clinical trial NCT03031028: Effect of Outpatient Classic Ketogenic Diet in Epileptic Children and Adolescent.
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Refractory Epilepsy
Keywords: refractory epilepsy,
ketogenic diet
classic ketogenic diet
seizure rate
efficacy
epilepsy
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: seizure rate
timeFrame: 3 months
Secondary outcomes:
measure: Height
timeFrame: Before and after 1 and 3 months on the classical KD.
measure: Investigating side effects
timeFrame: After 3 months on the classical KD
measure: serum Triglyceride
timeFrame: Before and after 3 months on the classical KD
measure: Weight
timeFrame: Before and after 1 and 3 months on the classical KD.
measure: serum Cholesterol,
timeFrame: Before and after 3 months on the classical KD
measure: serum LDL-Cholesterol
timeFrame: Before and after 3 months on the classical KD.
measure: serum HDL-Cholesterol
timeFrame: Before and after 3 months on the classical KD
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran university of medical science, school of nutritional science and dietetics
Study officials:
affiliation: Tehran university of medical science, school of Nutritional science and Dietetics
name: Maryam Mahmoudi, MD, PHD
role: STUDY_DIRECTOR
References: