Prospective Study of Comparison Between the Modified Atkins Diet and Classic Ketogenic Diet for Intractable Childhood Epilepsy

Study Overview
=================
Brief Summary
-----------------
The Ketogenic diet is a now proven, evidence based treatment of refractory epilepsy. the classic ketogenic diet (KD) is based on a ratio of fat to carbohydrate and protein, usually 3:1 or 4:1. Fat is proven long-chain triglycerides. The efficacy of the KD has been proven by many multicenter trials. But, side effects of ketogenic diet therapy is severe. The modified atkins diet (MAD) was designed and investigated at Johns Hopkins Hospital, which aimed to propose a less restrictive dietary treatment that would be more palatable to children and adolescents with less side effects. The MAD consist of a nearly balance diet (60% fat, 30% protein, and 10% carbohydrates by weight), without any restriction on the recommended daily calories. Some literature suggested that the MAD is an effective treatment for refractory epilepsy. But, no randomised controlled study has been tried. the investigators aimed in this prospective study to evaluate the efficacy, safety and tolerability of MAD comparing to KD. The patients were recruited between age 3 to 18 years old with intractable epilepsy. Enrolled patients were randomly assigned to either one of two groups; the KD group and MAD group. The patients were required to attend outpatient clinic after 1, 3month to record their seizure frequency and severity, while their dietary treatment.

Conditions
-----------------
Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ranged from 1 to 18 year old patients diagnosed with intractable epilepsy which shows frequency with more than 1 per week, 4 per month even though at least more than 2 antiepileptic drug treatment. Exclusion Criteria Patients heve been tried KD or MAD before. Patients with renal stones, hyperlipidemia, cardiologic problems. Other conditions not adjust for dietary therapy.

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Atkins diet group<br>pediatric patients diagnosed with intractable epilepsy. Their ages ranged between 1 to 18 years amd indicated to dietary therapy. the targeting number of patients was 53. enrolled patients are assigned to randomly in one of KD group or Atkins group. | |
| Ketogenic diet group<br>pediatric patients diagnosed with intractable epilepsy. Their ages ranged between 1 to 18 years amd indicated to dietary therapy. the targeting number of patients was 51. enrolled patients are assigned to randomly in one of KD group or Atkins group. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| seizure outcome 3months after dietary therapy. | 1 and 3 month after dietary therapy, enrolled patients were required to visit outpatient clinic to record their seizure frequency. we compile statistics and compare seizure frequencies before and after dietary treatment in each KD group and MAD group. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Seizure control through dietary therapy in pediatric intractable epilepsy patients.