Exogenous Ketone Esters for Drug Resistant Epilepsy
Recruiting · NCT05670847 · Interventional (participants receive a specific treatment) · Lead sponsor: Sohag University
View the official record on ClinicalTrials.gov →Interventions studied
Exogenous ketone ester
What this trial is about
This study aims to investigate the efficacy of add-on exogenous ketone esters for treating children with drug-resistant epilepsy
Who can take part
Age range
1 Year to 16 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Drug-resistant epilepsy
- Seizure frequency ≥ 7 per week
Exclusion criteria
- Failure to obtain informed consent
- Recent intake of exogenous ketones, ketogenic diet, or any dietary restrictions/modifications
- Severe disease conditions, including hepatic, renal, respiratory, cardiac, gastrointestinal, endocrinal, and immune systems
- Hypo-/hyperglycemia
- Metabolic acidosis
- Ketosis (βHB \> 2 mmol/L)
- GIT disorders, including gastritis/peptic ulcer, diarrhea/constipation, and irritable bowel disease
- Malnutrition/obesity
- Limitations to oral feeding (e.g., severe gastroesophageal reflux)
- Inborn errors of metabolism
- Chromosomal disorders
- Surgically-remediable epilepsy
- Allergies or any other contraindication to ketone supplements
- Inapplicable recording of seizures
- Incompliance to anti-seizure medications and/or irregular follow-up
- Recent propofol therapy
- Intake of carbonic-anhydrase inhibitors
Where it is running
1 location listed.
- Department of Pediatrics at Sohag University Hospital - Sohag, Egypt