Modified Atkins Diet in Children and Adolescents With Drug-resistant Epilepsy
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Modified Atkins Diet in Children and Adolescents With Drug-resistant Epilepsy - a Prospective Pilot Trial|
- Seizure frequency [ Time Frame: 6 months ] [ Designated as safety issue: No ]Seizure frequency is assessed after 1 month, 3 months and 6 months.
- Ambulatory EEG [ Time Frame: After 6 months ] [ Designated as safety issue: No ]24-hours EEG before diet treatment and after 6 months on the diet.
- Body Weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]Body weight was measured before diet treatment, after 1 month, 3 months and 6 months.
- Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]Questionnaire assessing quality of life and life on a strict diet, assessed after one, three and six months.
- Ketosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]Ketosis in blood and urine measured during the whole study period
- Dietary records [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]3-days dietary records were obtained after two and ten weeks on the diet.
|Study Start Date:||May 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Experimental: The Modified Atkins Diet
Treatment with the Modified Atkins Diet for 6 months
Other: The Modified Atkins Diet
The Modified Atkins Diet; 10 g carbohydrate per day and a high fat intake
Other Name: Ketogenic diet
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278966
|The National Centre for Child Epilepsy|
|Pb. 53, Bærum Postterminal, Norway, 1306|
|Study Chair:||Morten Lossius, Phd||Oslo University Hospital|