The modified Atkins diet for epilepsy: an RCT.

Recruiting

• Conditions: Keywords:Refractory EpilepsyIntellectual disabilityModified Atkins DietIn Dutch: Refractaire epilepsie Verstandelijke beperkingGemodificeerde Atkins dieet

• Registration Number: NL-OMON21112
• Lead Sponsor: Tergooiziekenhuizen

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 54

Inclusion Criteria

•Age > 18 years, moderate to severe ID;

•Refractory epilepsy, defined as failure of two tolerated and appropriately chosen and used AED schedules;

Exclusion Criteria

•Undergone epilepsy surgery in the last 6 months, or awaiting presurgical evaluation;

•Underwent implantation of a vagal nerve stimulation in the last 6 months;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main study parameter will be the number of responders 4 months after randomization, compared between the intervention and the control group. Responder is defined by >50% reduction in seizure frequency.

Secondary Outcome Measures

Name	Time	Method
Retention of the diet; change in daily functioning; feasibility of the MAD in this population and setting; adverse events attributable to the MAD; predictive factors of efficacy of the diet.