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.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Other: The Modified Atkins 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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bærum Postterminal
    • Pb. 53, Bærum Postterminal, Norway, 1306
      • The National Centre for Child Epilepsy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Ketogenic diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure frequency	Seizure frequency is assessed after 1 month, 3 months and 6 months.	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Study Chair: Morten Lossius, Phd, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): December 1, 2010

Study Registration Dates

• First Submitted: December 29, 2010
• First Submitted That Met QC Criteria: January 17, 2011
• First Posted (ESTIMATE): January 19, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 19, 2011
• Last Update Submitted That Met QC Criteria: January 17, 2011
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Epilepsy; Diet; Ketogenic diet; the Modified Atkins Diet
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Drug Resistant Epilepsy
• Other Study ID Numbers: S-09180a (REK)