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

Epilepsy Clinical Trial

Official title:

Modified Atkins Diet in Children and Adolescents With Drug-resistant Epilepsy - a Prospective Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01278966
• Other study ID #: S-09180a (REK)
• Status: Completed
• Phase: N/A
• First received: December 29, 2010
• Last updated: January 17, 2011
• Start date: May 2009
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Other:
• The Modified Atkins Diet
The Modified Atkins Diet; 10 g carbohydrate per day and a high fat intake

Locations

Country	Name	City	State
Norway	The National Centre for Child Epilepsy	Pb. 53	Bærum Postterminal

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizure frequency	Seizure frequency is assessed after 1 month, 3 months and 6 months.	6 months	No
Secondary	Ambulatory EEG	24-hours EEG before diet treatment and after 6 months on the diet.	After 6 months	No
Secondary	Body Weight	Body weight was measured before diet treatment, after 1 month, 3 months and 6 months.	6 months	No
Secondary	Quality of life	Questionnaire assessing quality of life and life on a strict diet, assessed after one, three and six months.	6 months	No
Secondary	Ketosis	Ketosis in blood and urine measured during the whole study period	6 months	No
Secondary	Dietary records	3-days dietary records were obtained after two and ten weeks on the diet.	10 weeks	No