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

Epilepsy Intractable Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03014752
• Other study ID #: 9311468002
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 31, 2016
• Last updated: September 2, 2017
• Start date: September 2016
• Est. completion date: May 2017

Study information

• Verified date: December 2016
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Epilepsy Intractable

Intervention

Other:
• Classical ketogenic diet
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.
• Modified Atkins diet
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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Childrens' Medical Center, Tehran University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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