Ketogenic diet for treating epilepsy in children
The Efficacy of Ketogenic Diet in Treating Pediatric Intractable Epilepsy and Its Relationship With Changes in Inflammatory Markers
This study tests if a ketogenic diet can help children with hard-to-treat epilepsy feel better and reduce inflammation compared to standard medications alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 59 (estimated) |
| Ages | 6 Months to 12 Years |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06310954 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a ketogenic diet in managing pediatric intractable epilepsy while also examining its effects on inflammatory markers. A total of 59 participants will be recruited, with 39 receiving a combination of the ketogenic diet and conventional antiepileptic medications, and 20 receiving only conventional treatments. The study will measure various efficacy indicators, including seizure frequency and inflammatory factor levels, to assess the potential benefits of the ketogenic diet as a treatment strategy.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 months to 12 years diagnosed with intractable epilepsy experiencing more than four seizures per month.
Not a fit: Patients with metabolic diseases or those contraindicated for the ketogenic diet may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new dietary treatment option for children suffering from intractable epilepsy.
How similar studies have performed: Previous studies have shown promising results with ketogenic diets in epilepsy management, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Fat metabolism or other metabolic diseases * febrile or infectious periods * contraindications to the ketogenic diet * children suitable for surgery or parents refusing drug and diet intervention.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat Sen Memorial Hospital， Sun Yat Sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: DongFang Li
- Email: Tangdx6@mail.sysu.edu.cn
- Phone: +8615509888556
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.