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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
History of Changes
  Purpose

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.


Condition Intervention
Epilepsy
 Other: The Modified Atkins Diet

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Seizure frequency [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Seizure frequency is assessed after 1 month, 3 months and 6 months.


Secondary Outcome Measures:
  • 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.


Enrollment: 21
Study Start Date: May 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278966

Locations
Norway
The National Centre for Child Epilepsy
Pb. 53, Bærum Postterminal, Norway, 1306
Sponsors and Collaborators
Oslo University Hospital
Investigators
Study Chair: Morten Lossius, Phd Oslo University Hospital
  More Information

No publications provided

Responsible Party: Kathrine Haavardsholm, Oslo University Hospital, Division of Surgery and Clinical Neuroscience, National Centre for Child Epilepsy
ClinicalTrials.gov Identifier: NCT01278966     History of Changes
Other Study ID Numbers: S-09180a (REK)
Study First Received: December 29, 2010
Last Updated: January 17, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Epilepsy
Diet
the Modified Atkins Diet
Ketogenic diet

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013