search
Back to results

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

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
The Modified Atkins Diet
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Diet, the Modified Atkins Diet, Ketogenic diet

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The National Centre for Child Epilepsy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The Modified Atkins Diet

Arm Description

Treatment with the Modified Atkins Diet for 6 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 29, 2010
Last Updated
January 17, 2011
Sponsor
Oslo University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01278966
Brief Title
Modified Atkins Diet in Children and Adolescents With Drug-resistant Epilepsy
Official Title
Modified Atkins Diet in Children and Adolescents With Drug-resistant Epilepsy - a Prospective Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, Diet, the Modified Atkins Diet, Ketogenic diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The Modified Atkins Diet
Arm Type
Experimental
Arm Description
Treatment with the Modified Atkins Diet for 6 months
Intervention Type
Other
Intervention Name(s)
The Modified Atkins Diet
Other Intervention Name(s)
Ketogenic diet
Intervention Description
The Modified Atkins Diet; 10 g carbohydrate per day and a high fat intake
Primary Outcome Measure Information:
Title
Seizure frequency
Description
Seizure frequency is assessed after 1 month, 3 months and 6 months.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Ambulatory EEG
Description
24-hours EEG before diet treatment and after 6 months on the diet.
Time Frame
After 6 months
Title
Body Weight
Description
Body weight was measured before diet treatment, after 1 month, 3 months and 6 months.
Time Frame
6 months
Title
Quality of life
Description
Questionnaire assessing quality of life and life on a strict diet, assessed after one, three and six months.
Time Frame
6 months
Title
Ketosis
Description
Ketosis in blood and urine measured during the whole study period
Time Frame
6 months
Title
Dietary records
Description
3-days dietary records were obtained after two and ten weeks on the diet.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morten Lossius, Phd
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
The National Centre for Child Epilepsy
City
Pb. 53
State/Province
Bærum Postterminal
ZIP/Postal Code
1306
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs