Study Results
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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RECRUITING
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2023-01-10
2025-07-01
Brief Summary
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Detailed Description
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KD has been classically used for treating children with DRE. However, KD requires strict dietary restriction, which may not be applicable or acceptable for many patients, and is associated with several adverse effects, commonly including gastrointestinal (e.g., constipation, nausea, vomiting), cardiovascular (e.g., dyslipidemia), renal/genitourinary (e.g., renal calculi), and growth problems. Exogenous ketone esters (EKE) could be a more convenient and superior alternative to KD for children with DRE.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Study group
Children receiving exogenous ketone esters + standard of care
Exogenous ketone ester
500 mg/kg orally three times daily (with at least 4 hours between each dose) for 28 days
Control group
Children receiving only standard of care
No interventions assigned to this group
Interventions
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Exogenous ketone ester
500 mg/kg orally three times daily (with at least 4 hours between each dose) for 28 days
Eligibility Criteria
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Inclusion Criteria
* Seizure frequency ≥ 7 per week
Exclusion Criteria
* 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
1 Year
16 Years
ALL
No
Sponsors
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Sohag University
OTHER
Responsible Party
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Elsayed Abdelkreem
Lecturer of Pediatrics
Principal Investigators
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Abdelrahim A Sadek, MD, PhD
Role: STUDY_CHAIR
Sohag University
Locations
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Department of Pediatrics at Sohag University Hospital
Sohag, , Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Carson RP, Herber DL, Pan Z, Phibbs F, Key AP, Gouelle A, Ergish P, Armour EA, Patel S, Duis J. Nutritional Formulation for Patients with Angelman Syndrome: A Randomized, Double-Blind, Placebo-Controlled Study of Exogenous Ketones. J Nutr. 2021 Dec 3;151(12):3628-3636. doi: 10.1093/jn/nxab284.
Clarke K, Tchabanenko K, Pawlosky R, Carter E, Todd King M, Musa-Veloso K, Ho M, Roberts A, Robertson J, Vanitallie TB, Veech RL. Kinetics, safety and tolerability of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate in healthy adult subjects. Regul Toxicol Pharmacol. 2012 Aug;63(3):401-8. doi: 10.1016/j.yrtph.2012.04.008. Epub 2012 May 3.
Stubbs BJ, Cox PJ, Evans RD, Santer P, Miller JJ, Faull OK, Magor-Elliott S, Hiyama S, Stirling M, Clarke K. On the Metabolism of Exogenous Ketones in Humans. Front Physiol. 2017 Oct 30;8:848. doi: 10.3389/fphys.2017.00848. eCollection 2017.
Cox PJ, Kirk T, Ashmore T, Willerton K, Evans R, Smith A, Murray AJ, Stubbs B, West J, McLure SW, King MT, Dodd MS, Holloway C, Neubauer S, Drawer S, Veech RL, Griffin JL, Clarke K. Nutritional Ketosis Alters Fuel Preference and Thereby Endurance Performance in Athletes. Cell Metab. 2016 Aug 9;24(2):256-68. doi: 10.1016/j.cmet.2016.07.010. Epub 2016 Jul 27.
Gilbert DL, Pyzik PL, Freeman JM. The ketogenic diet: seizure control correlates better with serum beta-hydroxybutyrate than with urine ketones. J Child Neurol. 2000 Dec;15(12):787-90. doi: 10.1177/088307380001501203.
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.
Scheffer IE, Berkovic S, Capovilla G, Connolly MB, French J, Guilhoto L, Hirsch E, Jain S, Mathern GW, Moshe SL, Nordli DR, Perucca E, Tomson T, Wiebe S, Zhang YH, Zuberi SM. ILAE classification of the epilepsies: Position paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017 Apr;58(4):512-521. doi: 10.1111/epi.13709. Epub 2017 Mar 8.
Walker I, Said RR. Predictors of Ketogenic Diet Efficacy in Children Based on the Electroencephalogram (EEG). J Child Neurol. 2015 Sep;30(10):1270-4. doi: 10.1177/0883073814556888. Epub 2014 Nov 20.
Other Identifiers
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Soh-Med-22-12-45
Identifier Type: -
Identifier Source: org_study_id