Clinical trial NCT06310954: Ketogenic Diet in Pediatric Intractable Epilepsy
Official title: The Efficacy of Ketogenic Diet in Treating Pediatric Intractable Epilepsy and Its Relationship With Changes in Inflammatory Markers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy in Children
Epilepsy Intractable
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 59
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Epilepsy Control Response Rate
timeFrame: During the study period (16 weeks)
Secondary outcomes:
measure: Inflammatory Marker Levels
timeFrame: During the study period (16 weeks)]
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat Sen Memorial Hospital， Sun Yat Sen University
state: Guangdong
Study officials:
References:
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