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Completed

NCT Number: NCT01311440

Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy

In Oslo University Hospital, department of complex epilepsy, offer ketogenic diet to treat children with medically intractable epilepsy. From 2009 we added modified Atkins diet as a treatment option for children up to 18 years.

We now initiate an open, prospective, randomized and controlled study with the aim to test the efficacy of treatment with modified Atkins diet in adults with focal and generalized epilepsy diagnoses, in order to evaluate whether this treatment should be offered to patients on a permanent basis.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy, Generalized Focal Epilepsy Generalized Epilepsy Nervous System Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital, The national Centre for epilepsy

Sandvika, Bærum Postterminal, 1306, Norway

About this study

Poorly controlled epilepsy in adults affects health and quality of life in many ways. Within this heterogenous population there are individuals who are motivated for a very strict diet in order to reduce seizures.

Among adults with epilepsy 75 - 80 % are diagnosed with focal epilepsy, while 20 - 25 % have generalized onset of seizures.

We plan to include 92 patients with focal epilepsy diagnosis. Those are randomized into diet and control groups.

During the inclusion period we also treat patients with generalized epilepsy that qualify for participation, but these are not to be randomized, rather they will follow the diet group course. We assume 18 - 23 patients with generalized epilepsy will be included in the project.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Focal or generalized epilepsy diagnosis
  • More than 3 recordable seizures per month
  • BMI > 18,5
  • Not responded to at least three 3 AEDs
  • 16 years or older
  • Motivated to complete the diet after thorough information
  • Capable of recording seizures
  • Capable of preparing the diet

Exclusion criteria

  • Hypercholesterolemia, cardiovascular disease or kidney disease
  • Been on modified Atkins diet for more than one week during the last year
  • Status epilepticus last six months
  • epilepsy surgery or VNS implant last year
  • 4 weeks continuous seizure freedom last 2 months
  • PNES seizures
  • other disease where dietary treatment is contraindicated
  • usage of drugs or supplements that may interfere with diet or AED
  • being pregnant or planning pregnancy

Treatment and study plan

Modified Atkins diet treatment

Other

Eat a diet containing 16 grams of carbohydrates per day, maximize on fat. Assure sufficient intake of micronutrients.

Primary outcomes

  1. Change in seizure frequency

    Time frame: 12 weeks

    All participants record detailed seizure records for 12 weeks prior to the control/diet period. The diet group participants are subsequently treated with modified Atkins diet for 12 weeks, while the control group continue their normal diet and record seizures for another 12 weeks. Seizure records for each participant before and during intervention are compared.

Secondary outcomes

  1. Change in body weight

    Time frame: 12 weeks

  2. Change in standard 3-hrs EEG

    Time frame: 12 weeks

  3. Change in life quality measured by validated questionnaire

    Time frame: 12 weeks

  4. Change in various blood and serum measures

    Time frame: 12 weeks

  5. Change in executive functions measured with validated questionnaire

    Time frame: 12 weeks

  6. Change in seizure strength and severity measured by validated questionnaire

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Modified Atkins Diet Treatment for Adults With Drug-resistant Epilepsy - a Controlled, Randomized Trial

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Mar 9, 2011
Registry last updated
Sep 19, 2017

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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