Clinical trial NCT03014752: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Epilepsy Intractable
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2017-01-09
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Comparison of the efficacy of the outpatient classical ketogenic diet and modified atkins diet
timeFrame: Prior to and three months after initiation of the classical ketogenic diet and modified Atkins diet
Secondary outcomes:
measure: Comparison of the nutritional status of children and adolescents on the classical KD and MAD
timeFrame: Baseline and three months after initiation of the classical ketogenic diet and modified Atkins diet
measure: Comparison of the lipid profiles of children and adolescents on the classical KD and MAD
timeFrame: Baseline and three months after initiation of the classical ketogenic diet and modified Atkins diet
measure: Comparison of the serum electrolytes levels of children and adolescents on the classical KD and MAD
timeFrame: Baseline and three months after initiation of the classical ketogenic diet and modified Atkins diet
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Childrens' Medical Center, Tehran University of Medical Sciences
Study officials:
References: