Modified Atkins Diet in Children and Adolescents With Drug-resistant Epilepsy
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|