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Correlation between blood ketone level and efficacy in ketogenic diet for children with drug-resistant epilepsy

Correlation between blood ketone level and efficacy in ketogenic diet for children with drug-resistant epilepsy: a prospective cohort study

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400079789
Enrollment
Unknown
Registered
2024-01-12
Start date
2024-01-15
Completion date
Unknown
Last updated
2024-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

drug-resistant epilepsy

Interventions

High blood ketone group (Ketone body level =4mmol/L) :None
Low blood ketone group (Ketone body level <4mmol/L) :None

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: (1) Patients diagnosed with drug-resistant epilepsy as defined by ILAE 2010 (correctly selected and tolerated two anti-seizure drugs, single or combined use still cannot achieve sustained seizure free); (2) From January 2024 to January 2025 in Peking University First Hospital; (3) Age 0-18 years old; (4) Patients treated with classical ketogenic diet (classic ketogenic diet regimen); (5) Voluntarily join the study patients through informed consent.

Exclusion criteria

Exclusion criteria: (1) Clear the absolute contraindications of keto diet treatment: fatty acid metabolism disorders and biological oxidation abnormalities related diseases, such as porphyria, pyruvate carboxylase deficiency, long and medium chain 3-hydroxyacyl-coA deficiency, long and short chain acyl-dehydrogenase deficiency, carnitine deficiency (primary), carnitine palmitoyl transferase ? or ? deficiency, carnitine transtransferase deficiency; (2) Clarify the relative contraindications of ketogenic diet therapy: ketogenic diet therapy can not maintain adequate nutrition or do not cooperate with (severe malnutrition, severe vomiting and diarrhea), suitable for excision surgery (such as epileptogenic focus is clear and resectable); (3) Combined with serious cardiopulmonary and blood system diseases, liver and kidney function impairment, severe hyperlipidemia, urinary calculi or serious gastroesophageal reflux and other diseases; (4) Patients refused to join the study.

Design outcomes

Primary

MeasureTime frame
Responder rate of ketogenic diet at 3 months;

Secondary

MeasureTime frame
Responder rates of ketogenic diet at 6,9, and 12 months;Rates of adverse effects during ketogenic diet;

Countries

China

Contacts

Public ContactJie Zhang

Peking University First Hospital

zhangjie2013bjmu@163.com+86 186 1403 1690

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026