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Completed

NCT Number: NCT01278966

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

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.

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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The National Centre for Child Epilepsy

Pb. 53, Bærum Postterminal, 1306, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Modified Atkins Diet

Other

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

Other names: Ketogenic diet

Primary outcomes

  1. Seizure frequency

    Time frame: 6 months

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

Secondary outcomes

  1. Ambulatory EEG

    Time frame: After 6 months

    24-hours EEG before diet treatment and after 6 months on the diet.

  2. Body Weight

    Time frame: 6 months

    Body weight was measured before diet treatment, after 1 month, 3 months and 6 months.

  3. Quality of life

    Time frame: 6 months

    Questionnaire assessing quality of life and life on a strict diet, assessed after one, three and six months.

  4. Ketosis

    Time frame: 6 months

    Ketosis in blood and urine measured during the whole study period

  5. Dietary records

    Time frame: 10 weeks

    3-days dietary records were obtained after two and ten weeks on the diet.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 19, 2011
Registry last updated
Jan 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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