Ketogenic Diet in Pediatric Intractable Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-11

Study Completion Date

2024-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Epilepsy in Children Epilepsy Intractable

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Early ketogenic diet combined with conventional pharmacotherapy.

Intervention Type DIETARY_SUPPLEMENT

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.

Common diet combined with conventional pharmacotherapy

Intervention Type DRUG

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, and inflammatory markers, and identifying patient characteristics associated with treatment responsiveness.We know that drug information for registering clinical information is necessary, but our research design is to add ketogenic diets as a supplementary treatment plan when traditional drug treatment is ineffective. Therefore, in terms of specific drug selection, this is not absolutely the same. Depending on individual differences, the choice of drugs will also vary. Control the number of episodes, time, etc., and everyone uses different drugs. Therefore, we cannot decide on a single drug for comparison like traditional content.

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.

Group Type PLACEBO_COMPARATOR

Early ketogenic diet combined with conventional pharmacotherapy.

Intervention Type DIETARY_SUPPLEMENT

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.

Common diet combined with conventional pharmacotherapy

Intervention Type DRUG

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, and inflammatory markers, and identifying patient characteristics associated with treatment responsiveness.We know that drug information for registering clinical information is necessary, but our research design is to add ketogenic diets as a supplementary treatment plan when traditional drug treatment is ineffective. Therefore, in terms of specific drug selection, this is not absolutely the same. Depending on individual differences, the choice of drugs will also vary. Control the number of episodes, time, etc., and everyone uses different drugs. Therefore, we cannot decide on a single drug for comparison like traditional content.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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, and inflammatory markers, and identifying patient characteristics associated with treatment responsiveness.We know that drug information for registering clinical information is necessary, but our research design is to add ketogenic diets as a supplementary treatment plan when traditional drug treatment is ineffective. Therefore, in terms of specific drug selection, this is not absolutely the same. Depending on individual differences, the choice of drugs will also vary. Control the number of episodes, time, etc., and everyone uses different drugs. Therefore, we cannot decide on a single drug for comparison like traditional content.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No