NL-OMON40609CompletedNot Applicable
The modified Atkins diet in patients with refractory epilepsy and severe intellectual disability: a randomized controlled trial. - The modified Atkins diet in epilepsy: an RCT.
Tergooiziekenhuizen0 sites29 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 29
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Age > 18 years, moderate to severe ID;
- •Refractory epilepsy, defined as failure of two tolerated and appropriately chosen and used AED schedules;
- •More than two seizures per month, which are judged by the carers and the treating physician to impose a significant impact on the patients* QOL --justifying treatment;
- •Informed consent obtained by at least one legal representative;
Exclusion Criteria
- •Undergone epilepsy surgery in the last 6 months, or awaiting pre-surgical evaluation;
- •Underwent implantation of a vagal nerve stimulation in the last 6 months;
- •Previous use of the MAD or the KD for more than 7 days in the last year prior to inclusion;
- •Hypercholesterolemia (total cholesterol >8), cardiovascular disease or kidney failure, metabolic disorders known to deteriorate after fasting;
- •Severe underweight, defined as a BMI < 16.5;
- •Diabetes Mellitus.
Investigators
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