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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01278966
Enrollment
21
Registered
2011-01-19
Start date
2009-05-31
Completion date
2010-12-31
Last updated
2011-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

Epilepsy, Diet, the Modified Atkins Diet, Ketogenic diet

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.

Interventions

OTHERThe Modified Atkins Diet

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

Sponsors

Oslo University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Seizure frequency6 monthsSeizure frequency is assessed after 1 month, 3 months and 6 months.

Secondary

MeasureTime frameDescription
Ambulatory EEGAfter 6 months24-hours EEG before diet treatment and after 6 months on the diet.
Body Weight6 monthsBody weight was measured before diet treatment, after 1 month, 3 months and 6 months.
Quality of life6 monthsQuestionnaire assessing quality of life and life on a strict diet, assessed after one, three and six months.
Ketosis6 monthsKetosis in blood and urine measured during the whole study period
Dietary records10 weeks3-days dietary records were obtained after two and ten weeks on the diet.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026