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

Not Applicable

Completed

• Conditions: Epilepsy
• Interventions: Other: The Modified Atkins Diet

• Registration Number: NCT01278966
• Lead Sponsor: Oslo University Hospital

Brief Summary

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.

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.

Study Timeline

• Study Start: 2009-05
• Status Verified: 2010-12
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2010-12-29
• Study First Submitted QC: 2011-01-17
• Last Update Submitted: 2011-01-17
• Study First Posted: 2011-01-19
• Last Update Posted: 2011-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The Modified Atkins Diet	The Modified Atkins Diet	Treatment with the Modified Atkins Diet for 6 months

Primary Outcome Measures

Name	Time	Method
Seizure frequency	6 months	Seizure frequency is assessed after 1 month, 3 months and 6 months.

Secondary Outcome Measures

Name	Time	Method
Ambulatory EEG	After 6 months	24-hours EEG before diet treatment and after 6 months on the diet.
Body Weight	6 months	Body weight was measured before diet treatment, after 1 month, 3 months and 6 months.
Quality of life	6 months	Questionnaire assessing quality of life and life on a strict diet, assessed after one, three and six months.
Ketosis	6 months	Ketosis in blood and urine measured during the whole study period
Dietary records	10 weeks	3-days dietary records were obtained after two and ten weeks on the diet.

Trial Locations

Locations (1)

The National Centre for Child Epilepsy; 🇳🇴 Pb. 53, Bærum Postterminal, Norway