Modified Atkins Diet in Children and Adolescents With Drug-resistant Epilepsy
|ClinicalTrials.gov Identifier: NCT01278966|
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : January 19, 2011
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Other: The Modified Atkins Diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Modified Atkins Diet in Children and Adolescents With Drug-resistant Epilepsy - a Prospective Pilot Trial|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
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
- Seizure frequency [ Time Frame: 6 months ]Seizure frequency is assessed after 1 month, 3 months and 6 months.
- Ambulatory EEG [ Time Frame: After 6 months ]24-hours EEG before diet treatment and after 6 months on the diet.
- Body Weight [ Time Frame: 6 months ]Body weight was measured before diet treatment, after 1 month, 3 months and 6 months.
- Quality of life [ Time Frame: 6 months ]Questionnaire assessing quality of life and life on a strict diet, assessed after one, three and six months.
- Ketosis [ Time Frame: 6 months ]Ketosis in blood and urine measured during the whole study period
- Dietary records [ Time Frame: 10 weeks ]3-days dietary records were obtained after two and ten weeks on the diet.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278966
|The National Centre for Child Epilepsy|
|Pb. 53, Bærum Postterminal, Norway, 1306|
|Study Chair:||Morten Lossius, Phd||Oslo University Hospital|