NCT06703983Completed
Efficacy of Low Glycemic Index Diet Versus Classic Ketogenic Diet in Pediatric Epilepsy Treatment
Comparison of the Effect of Low Glycemic Index Diet Compared to the Classical Ketogenic Diet in Reducing the Number of Seizures in Children With Drug Resistant Epilepsy
Source: ClinicalTrials.gov · Last updated 5 Aug 2025
Brief summary (registry, in English)
Epilepsy is a common disease among children. Today, treating epilepsy remains a major challenge, with many children affected by this condition. According to reports, 30% of children with epilepsy do not respond well to treatment. Various methods are available for managing epilepsy, one of the most accepted therapies for this condition are dietary therapies. Numerous studies have shown that dietary therapy is an effective and can have reasonable response in treating seizure. The most commonly used dietary intervention is the Classic Ketogenic Diet (CKD). In the CKD, approximately 90% of calories come from fat, making it a highly restrictive regimen that causes significant challenges for children to follow. Many studies have reported low adherence rates due to its difficulty, with a substantial number of patients discontinuing the diet over time. Some studies have explored the use of the Low Glycemic Index Therapy(LGIT), another form of the ketogenic diet, in managing drug-resistant epilepsy can be successful. In the LGIT, 60% of energy is derived from fat, 30% from protein, and 10% from carbohydrates. Due to the reduced fat content and greater dietary flexibility, this diet has fewer side effects and is easier to follow. Studies have also shown higher adherence rates to LGIT compared to CKD. Although limited research is available on LGIT, existing studies suggest that it may be as effective as CKD in treating epilepsy. Given the widespread prevalence and severe complications associated with untreated epilepsy in children, Further research into dietary therapies is crucial, as untreated epilepsy can lead to irreversible damage in children. The aim of this study is to compare the effectiveness of the Low Glycemic Index therapy and the Classic Ketogenic Diet in epilepsy treatment. If LGIT proves to be as successful as CKD, it could be considered a suitable alternative for managing epilepsy. In this randomized clinical trial, 40 children with drug-resistant epilepsy will be enrolled. Participants will be selected from patients referred by Pediatric Neurologists to dietitians for ketogenic diet therapy. After obtaining informed consent, participants will be randomly assigned using a block randomization method to one of two groups: the LGIT group or the CKD group. At the end of three months, the two groups will be compared in terms of seizure frequency and duration using statistical tests. The effectiveness of LGIT relative to CKD will be reported.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 19 Nov 2024
- Start date
- 5 Dec 2024
- Primary completion date
- 10 Jul 2025
- Lead sponsor
- Mashhad University of Medical Sciences
- Diseases
- Epilepsy
- NCT number
- NCT06703983
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 5 Dec 2024 to the primary completion date, 10 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Parents' disapproval of the child's participation in the study Having liver and kidney diseases Doctor's disapproval based on the patient's condition Absolute contraindications to the ketogenic diet
Who the study is looking for
- Children between 2 and 18 years old who still have epilepsy despite receiving 2 or more medications
- Children with genetic disease need to receive ketogenic diet (pyruvate dehydrogenase deficiency and GLUT-1 transporter deficiency)
Age in the registry: 2 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mashhad University of Medical Sciences Coordinator of this site? Confirm its status | Mashhad | Iran | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.