NCT06310954

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 11, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

1.7 years

First QC Date

January 22, 2024

Last Update Submit

March 13, 2024

Conditions

Epilepsy in ChildrenEpilepsy Intractable

Outcome Measures

Primary Outcomes (1)

  • Epilepsy Control Response Rate

    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%.

    During the study period (16 weeks)

Secondary Outcomes (1)

  • Inflammatory Marker Levels

    During the study period (16 weeks)]

Study Arms (2)

Ketogenic Diet plus Conventional Treatment Group

EXPERIMENTAL

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.

Dietary Supplement: Early ketogenic diet combined with conventional pharmacotherapy.Drug: Common diet combined with conventional pharmacotherapy

Control Group: Conventional Treatment Group

PLACEBO COMPARATOR

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.

Dietary Supplement: Early ketogenic diet combined with conventional pharmacotherapy.Drug: Common diet combined with conventional pharmacotherapy

Interventions

Early ketogenic diet combined with conventional pharmacotherapy.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.

Control Group: Conventional Treatment GroupKetogenic Diet plus Conventional Treatment Group
Common diet combined with conventional pharmacotherapyDRUG

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 GroupKetogenic Diet plus Conventional Treatment Group

Eligibility Criteria

Age6 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat Sen Memorial Hospital， Sun Yat Sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (5)

  • Vezzani A, Maroso M, Balosso S, Sanchez MA, Bartfai T. IL-1 receptor/Toll-like receptor signaling in infection, inflammation, stress and neurodegeneration couples hyperexcitability and seizures. Brain Behav Immun. 2011 Oct;25(7):1281-9. doi: 10.1016/j.bbi.2011.03.018. Epub 2011 Apr 5.

    PMID: 21473909BACKGROUND

  • Wirrell E, Farrell K, Whiting S. The epileptic encephalopathies of infancy and childhood. Can J Neurol Sci. 2005 Nov;32(4):409-18. doi: 10.1017/s0317167100004388.

    PMID: 16408569BACKGROUND

  • Chen Z, Brodie MJ, Liew D, Kwan P. Treatment Outcomes in Patients With Newly Diagnosed Epilepsy Treated With Established and New Antiepileptic Drugs: A 30-Year Longitudinal Cohort Study. JAMA Neurol. 2018 Mar 1;75(3):279-286. doi: 10.1001/jamaneurol.2017.3949.

    PMID: 29279892BACKGROUND

  • Kwan P, Arzimanoglou A, Berg AT, Brodie MJ, Allen Hauser W, Mathern G, Moshe SL, Perucca E, Wiebe S, French J. Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia. 2010 Jun;51(6):1069-77. doi: 10.1111/j.1528-1167.2009.02397.x. Epub 2009 Nov 3.

    PMID: 19889013BACKGROUND

  • Loscher W, Potschka H, Sisodiya SM, Vezzani A. Drug Resistance in Epilepsy: Clinical Impact, Potential Mechanisms, and New Innovative Treatment Options. Pharmacol Rev. 2020 Jul;72(3):606-638. doi: 10.1124/pr.120.019539.

    PMID: 32540959BACKGROUND

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

DongFang Li

CONTACT

+8615509888556Tangdx6@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2024

First Posted

March 15, 2024

Study Start

August 11, 2022

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)