Modified Atkins Diet in Children and Adolescents With Drug-resistant Epilepsy

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the effect of the Modified Atkins Diet in children and adolescents with drug-resistant epilepsy regarding seizure control, and to create a protocol for the use of the Modified Atkins Diet as a treatment for epilepsy in Norway.

Detailed Description
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The study is a prospective trial on the Modified Atkins Diet for children and adolescents with drug-resistant epilepsy. The Modified Atkins Diet is a less restrictive diet than the classical ketogenic diet, which is usually offered to this group of patients. Twenty patients between 2 and 18 years are included in the study, and the study period is 6 months. The study will be conducted at the National Centre for Child Epilepsy in Norway.

Official Title
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Modified Atkins Diet in Children and Adolescents With Drug-resistant Epilepsy - a Prospective Pilot Trial

Conditions
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Epilepsy

Intervention / Treatment
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* Other: The Modified Atkins Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age: 2-18 years At least 3 epileptic seizures per week Tried at least two anti-epileptic drugs without satisfactory seizure control Willing to try diet treatment for 6 months Exclusion Criteria: Too difficult for the family to adhere to a strict diet Not able to fill in a seizure calendar Local authorities will not approve the treatment VNS stimulator the last 12 months or changes made to VNS stimulator during the last three months Other disease where a diet high in fat is contra indicated Diet treatment is not possible because of poor intake of food or fluids Cortisol or other medication that influence energy metabolism or epileptic drug metabolism last month Patient has the last month used alternative medicine which may influence the diet Patient has tried the ketogenic fiet og Modified Atkins diet the last three years pregnancy

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Modified Atkins Diet<br>Treatment with the Modified Atkins Diet for 6 months | Other: The Modified Atkins Diet<br>* The Modified Atkins Diet; 10 g carbohydrate per day and a high fat intake<br>* Other names: Ketogenic diet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seizure frequency | Seizure frequency is assessed after 1 month, 3 months and 6 months. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulatory EEG | 24-hours EEG before diet treatment and after 6 months on the diet. | After 6 months | 
| Body Weight | Body weight was measured before diet treatment, after 1 month, 3 months and 6 months. | 6 months | 
| Quality of life | Questionnaire assessing quality of life and life on a strict diet, assessed after one, three and six months. | 6 months | 
| Ketosis | Ketosis in blood and urine measured during the whole study period | 6 months | 
| Dietary records | 3-days dietary records were obtained after two and ten weeks on the diet. | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, Diet, the Modified Atkins Diet, Ketogenic diet