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

NCT03014752 | Completed Phase 2 DMC

• 1 other identifier: 9311468002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Classical ketogenic diet

ACTIVE COMPARATOR

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

Modified Atkins diet

ACTIVE COMPARATOR

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

Interventions

Classical ketogenic diet OTHER

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.

Classical ketogenic diet

Modified Atkins diet OTHER

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.

Also known as: MAD

Modified Atkins diet

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Onset of complications that threat the life of the patient Inability to continue the diet Unwillingness to adhere the diet

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Childrens' Medical Center, Tehran University of Medical Sciences

Tehran, 1419733151, Iran

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

mycophenolic adenine dinucleotide

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2016
• First Posted: January 9, 2017
• Study Start: September 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: September 7, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)