The Efficacy of Ketogenic Diet in Treating Pediatric Intractable Epilepsy and Its Relationship With Changes in Inflammatory Markers
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study aims to evaluate the efficacy of a ketogenic diet in treating pediatric intractable epilepsy and to explore its relationship with changes in inflammatory markers. The investigators plan to recruit 59 participants with intractable epilepsy, 39 of whom will receive a combination of ketogenic diet and conventional antiepileptic drugs, while 20 will receive only conventional drugs. The study will assess the impact of the ketogenic diet on epilepsy control and inflammatory markers, hoping to discover new treatment strategies.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 12
Healthy Volunteers: f
View:
• Children aged 6 months to 12 years with a diagnosis of intractable epilepsy
• more than four seizures per month
• no metabolic diseases
• no severe liver or kidney dysfunction.
Locations
Other Locations
China
Sun Yat Sen Memorial Hospital， Sun Yat Sen University
RECRUITING
Guangzhou
Contact Information
Primary
DongFang Li
Tangdx6@mail.sysu.edu.cn
+8615509888556
Time Frame
Start Date: 2022-08-11
Estimated Completion Date: 2024-04-30
Participants
Target number of participants: 59
Treatments
Experimental: Ketogenic Diet plus Conventional Treatment Group
This arm of the trial explores the efficacy of an early initiation of the ketogenic diet in conjunction with conventional antiepileptic drugs (AEDs) for children with refractory epilepsy. The intervention aims to evaluate the impact on seizure frequency, and inflammatory markers, and identify patient characteristics predicting a better response to the ketogenic diet, to improve overall therapeutic response rates in refractory epilepsy.
Placebo_comparator: Control Group: Conventional Treatment Group
Participants in this arm will receive a standard diet without any ketogenic restrictions, alongside conventional antiepileptic drugs. This comparator aims to assess the standard care's efficacy against the experimental intervention, focusing on seizure control, inflammatory markers, and identifying patient characteristics associated with treatment responsiveness.
Sponsors
Leads: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University