The modified Atkins diet in patients with refractory epilepsy and severe intellectual disability: a randomized controlled trial.

Completed

Conditions: Refractory epilepsy - Drug-resistant epilepsy
10039911

Registration Number: NL-OMON40609

Lead Sponsor: Tergooiziekenhuizen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 29

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To analyse the efficacy of the Modified Atkins diet (MAD), defined as 50%<br /><br>reduction in seizure frequency at 4 months, compared to a control group.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives are:<br /><br>• To analyse retention rate of the MAD in this population, as a measure of<br /><br>overall effectiveness;<br /><br>• To analyse the efficacy of the MAD, defined as improvement of daily<br /><br>functioning, studied with the Habilitative Improvement Scale (HIS);<br /><br>• To assess the feasibility of the MAD in this population and this setting,<br /><br>with respect to logistics and adherence;<br /><br>• To assess (serious) adverse events attributable to the MAD;<br /><br>• To analyse which factors are associated with efficacy of the diet.</p><br>