Ketogenic Diet in Pediatric Intractable Epilepsy

Not Applicable

Recruiting

• Conditions: Epilepsy in Children; Epilepsy Intractable
• Interventions: Dietary Supplement: Early ketogenic diet combined with conventional pharmacotherapy.; Drug: Common diet combined with conventional pharmacotherapy

• Registration Number: NCT06310954
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief 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.

Detailed Description

Evaluation index

1. Safety: Adverse events related to the ketogenic diet

2. Efficacy evaluation:

A. Primary efficacy indicators: brain electrical load index, epilepsy control response rate, inflammatory factor 34 (blood, cerebrospinal fluid) Secondary efficacy indicators: epilepsy seizure-free rate B. Inspection indicators: blood ketone, blood sugar, blood biochemistry testing, etc.; C. Use high-throughput methods to detect absolute counts of cerebrospinal fluid, serum inflammatory factors, and whole blood lymphocyte subpopulations before and after adding a ketogenic diet.

Observation indicators

1. Measurement of ketone body levels Monitor blood ketones (beta-hydroxybutyrate) and blood ketones. Recording time: Record three times a day during the baseline period; record the average blood ketone value at each subsequent follow-up observation.

2. Frequency of epileptic seizures The frequency of epileptic seizures was recorded daily during the start-up period.

3. Efficacy evaluation:

Main efficacy indicators: epilepsy control response rate, seizure-free rate, inflammatory factor levels Epilepsy control response rate: defined as an absolute reduction of ≥50% in seizure frequency at follow-up compared with baseline

=(No attack + Marked effect + Effective)/Total number of cases × 100%. Evaluation of seizure control: No seizures: seizures are completely relieved after treatment; Markedly effective: the number of seizures is reduced by ≥75% after treatment; Effective: the number of seizures is reduced by ≥50% after treatment; Ineffective: the number of seizures is reduced by \<50% after treatment.

Seizure-free rate: Seizures were completely controlled at follow-up. = No attack cases/Total number of cases × 100%

4. Safety evaluation Record various adverse events; biochemical monitoring (glucose and lipid metabolism and related tests); other tests: necessary tests according to the condition (blood gas analysis, B-ultrasound, etc.);

5. Physical development Monitor and record height and weight, and conduct physical development evaluation.

6. Cognitive-behavioral development assessment The baseline period, KD weeks 4, 12, and KD week 16 (at the end of the efficacy observation period) were evaluated and recorded using the Gesell score scale.

Study Timeline

• Study Start: 2022-08-11
• Study First Submitted: 2024-01-22
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-13
• Last Update Submitted: 2024-03-13
• Study First Posted: 2024-03-15
• Last Update Posted: 2024-03-15
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketogenic Diet plus Conventional Treatment Group	Early ketogenic diet combined with conventional pharmacotherapy.	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.
Ketogenic Diet plus Conventional Treatment Group	Common diet combined with conventional pharmacotherapy	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.
Control Group: Conventional Treatment Group	Common diet combined with conventional pharmacotherapy	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.
Control Group: Conventional Treatment Group	Early ketogenic diet combined with conventional pharmacotherapy.	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.

Primary Outcome Measures

Name	Time	Method
Epilepsy Control Response Rate	During the study period (16 weeks)	Epilepsy control response rate: defined as an absolute reduction of ≥50% in seizure frequency at follow-up compared with baseline; =(No attack + Marked effect + Effective)/Total number of cases × 100%.

Secondary Outcome Measures

Name	Time	Method
Inflammatory Marker Levels	During the study period (16 weeks)]	This indicator aims to evaluate the effect of the ketogenic diet on the levels of inflammatory markers in the blood of children with refractory epilepsy to reveal the potential relationship between the effects of the ketogenic diet and inflammation levels.

Trial Locations

Locations (1)

Sun Yat Sen Memorial Hospital， Sun Yat Sen University; 🇨🇳 Guangzhou, Guangdong, China