Clinical Trial: 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 Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title:
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.
Detailed Summary:
Sponsor: Tehran University of Medical Sciences
Current Primary Outcome: Comparison of the efficacy of the outpatient classical ketogenic diet and modified atkins diet [ Time Frame: Prior to and three months after initiation of the classical ketogenic diet and modified Atkins diet ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Comparison of the nutritional status of children and adolescents on the classical KD and MAD [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline and three months after initiation of the classical ketogenic diet and modified Atkins diet ]
Original Secondary Outcome: Same as current
Information By: Tehran University of Medical Sciences
Dates:
Date Received: December 31, 2016
Date Started: September 2016
Date Completion: December 2017
Last Updated: January 5, 2017
Last Verified: December 2016
