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

This study has been completed.
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01278966
First received: December 29, 2010
Last updated: January 17, 2011
Last verified: December 2010

December 29, 2010
January 17, 2011
May 2009
December 2010   (final data collection date for primary outcome measure)
Seizure frequency [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Seizure frequency is assessed after 1 month, 3 months and 6 months.
Same as current
Complete list of historical versions of study NCT01278966 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Modified Atkins Diet in Children and Adolescents With Drug-resistant Epilepsy
Modified Atkins Diet in Children and Adolescents With Drug-resistant Epilepsy - a Prospective Pilot Trial

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Epilepsy
Other: The Modified Atkins Diet
The Modified Atkins Diet; 10 g carbohydrate per day and a high fat intake
Other Name: Ketogenic diet
Experimental: The Modified Atkins Diet
Treatment with the Modified Atkins Diet for 6 months
Intervention: Other: The Modified Atkins Diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
2 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01278966
S-09180a (REK)
No
Kathrine Haavardsholm, Oslo University Hospital, Division of Surgery and Clinical Neuroscience, National Centre for Child Epilepsy
Oslo University Hospital
Not Provided
Study Chair: Morten Lossius, Phd Oslo University Hospital
Oslo University Hospital
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP