Comparison of the Effectiveness of the Outpatient Classical Ketogenic Diet and Modified Atkins Diet on Seizures Frequency, Nutritional Status and Some Biochemical Factors in Children and Adolescents With Intractable Epilepsy

Study Overview
=================
Brief Summary
-----------------
Epilepsy is one of a common neurological disorder. Antiepileptic drugs (AEDs) are usually the primary treatment of epilepsy. However, almost 30% of patients do not respond to AEDs and other treatments including ketogenic diet (KD) are used. The Ketogenic Diet (KD) is a low-carbohydrate, high fat, adequate-protein diet. In this study, investigators are going to compare two kinds of the ketogenic diet namely classical ketogenic diet and modified Atkins diet. Fifty children and adolescents with intractable epilepsy will be included, 25 patients in each group, and will receive the diet for three months on non-randomised basis. In the classical ketogenic diet, the diet with a ratio of 4 to 1 (4:1), each 4 grams of fat to each gram of carbohydrate plus protein, will be introduced. Classical ketogenic diet will be established on outpatient setting, without fasting and gradually. The modified Atkins diet will be applied by the ratio of 1:1 or 2:1, each 1 or 2 grams of fat to each gram of carbohydrate plus protein.

Conditions
-----------------
Epilepsy Intractable

Intervention / Treatment
-----------------
* Other: Classical ketogenic diet
* Other: Modified Atkins diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children and adolescents age 1 to 18 years Have not responded well to at least two primary and one secondary antiepileptic drugs Have not received ketogenic diet therapy previously Absence of renal diseases history Absence of cardiovascular diseases history Absence of thyroid function disorders history Absence of cholesterol level more than 300 mg/dl and Triglyceride level more than 200 mg/dl Absence of inherited metabolic disorders that are contraindicated for ketogenic diet therapy including fatty acid oxidation disorders Exclusion Criteria: Onset of complications that threat the life of the patient Inability to continue the diet Unwillingness to adhere the diet

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Classical ketogenic diet<br>The classical ketogenic diet with 4:1 ketogenic ratio, each 4 grams of fat to each gram of carbohydrate plus protein, will be introduced. | Other: Classical ketogenic diet<br>* The classical ketogenic diet with a ratio of 4 to 1 (4:1), each 4 grams of fat to each gram of carbohydrate plus protein, will be introduced gradually.<br>|
| Active Comparator: Modified Atkins diet<br>The modified Atkins diet with a ratio of 1 or 2 to 1 (1:1, 2:1), each 1 or 2 grams of fat to each gram of carbohydrate plus protein, will be introduced gradually. | Other: Modified Atkins diet<br>* The modified Atkins diet with a ratio of 1 or 2 to 1 (1:1, 2:1), each 1 or 2 grams of fat to each gram of carbohydrate plus protein, will be introduced gradually.<br>* Other names: MAD;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the efficacy of the outpatient classical ketogenic diet and modified atkins diet |  | Prior to and three months after initiation of the classical ketogenic diet and modified Atkins diet | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the nutritional status of children and adolescents on the classical KD and MAD |  | Baseline and three months after initiation of the classical ketogenic diet and modified Atkins diet | 
| Comparison of the lipid profiles of children and adolescents on the classical KD and MAD |  | Baseline and three months after initiation of the classical ketogenic diet and modified Atkins diet | 
| Comparison of the serum electrolytes levels of children and adolescents on the classical KD and MAD |  | Baseline and three months after initiation of the classical ketogenic diet and modified Atkins diet |