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

NCT01278966 | Completed

• 1 other identifier: S-09180a (REK)
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

Epilepsy; Diet; the Modified Atkins Diet; Ketogenic diet

Outcome Measures

Primary Outcomes (1)

• Seizure frequency

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

  6 months

Secondary Outcomes (5)

• Ambulatory EEG

  After 6 months

• Body Weight

  6 months

• Quality of life

  6 months

• Ketosis

  6 months

• Dietary records

  10 weeks

Study Arms (1)

The Modified Atkins Diet

EXPERIMENTAL

Treatment with the Modified Atkins Diet for 6 months

Other: The Modified Atkins Diet

Interventions

The Modified Atkins Diet OTHER

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

Also known as: Ketogenic diet

The Modified Atkins Diet

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

The National Centre for Child Epilepsy

Pb. 53, Bærum Postterminal, 1306, Norway

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Morten Lossius, Phd

  Oslo University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 29, 2010
• First Posted: January 19, 2011
• Study Start: May 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 19, 2011

Record last verified: 2010-12

Locations

NO (1)