Back to resultsComparison 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
Primary Purpose
Epilepsy Intractable
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Classical ketogenic diet
Modified Atkins diet
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy Intractable
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
Sites / Locations
- Childrens' Medical Center, Tehran University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Classical ketogenic diet
Modified Atkins diet
Arm Description
The classical ketogenic diet with 4:1 ketogenic ratio, each 4 grams of fat to each gram of carbohydrate plus protein, will be introduced.
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.
Outcomes
Primary Outcome Measures
Comparison of the efficacy of the outpatient classical ketogenic diet and modified atkins diet
Secondary Outcome Measures
Comparison of the nutritional status of children and adolescents on the classical KD and MAD
Comparison of the lipid profiles of children and adolescents on the classical KD and MAD
Comparison of the serum electrolytes levels of children and adolescents on the classical KD and MAD
Full Information
NCT ID
NCT03014752
First Posted
December 31, 2016
Last Updated
September 2, 2017
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03014752
Brief Title
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
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy Intractable
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Classical ketogenic diet
Arm Type
Active Comparator
Arm Description
The classical ketogenic diet with 4:1 ketogenic ratio, each 4 grams of fat to each gram of carbohydrate plus protein, will be introduced.
Arm Title
Modified Atkins diet
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Classical ketogenic diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Modified Atkins diet
Other Intervention Name(s)
MAD
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Childrens' Medical Center, Tehran University of Medical Sciences
City
Tehran
ZIP/Postal Code
1419733151
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The IPD would not share with other researchers.
Learn more about this 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
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