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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 24, 2014