Effects of L-Carnitine on Gastric Emptying in Children With Drug Resistant Epilepsy on Ketogenic Diet

Not Applicable

Completed

• Conditions: Ketogenic Diet
• Interventions: Dietary Supplement: L- Carnitine; Other: ketogenic diet

• Registration Number: NCT06255873
• Lead Sponsor: Ain Shams University

Brief Summary

This study was conducted on thirty children aged from12 months to 18 years newly diagnosed with drug resistant epilepsy and following up at Pediatric Nutrition and Neurology Outpatient Clinics assigned randomly into 2 groups, group1: patients who started ketogenic diet with L-carnitine and group2: patients who started ketogenic diet only.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-20
• Primary Completion: 2023-09-22
• Study Completion: 2023-11-15
• Status Verified: 2024-02
• Study First Submitted: 2024-02-03
• Study First Submitted QC: 2024-02-03
• Study First Posted: 2024-02-13
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• All infants and children aged from 12 months to 18 years old newly diagnosed with drug resistant epilepsy and were assigned to start KD.

Exclusion Criteria

• Patients with intolerance or non-compliance to ketogenic diet therapy.
• Patients for epilepsy surgery or vagal nerve stimulation.
• Children with history of previous abdominal operations.
• Children with history of GI diseases affecting GI motility before starting KD.
• Children with tube feeding or feeding gastrostomy or jejunostomy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ketogenic diet with L - Carnitine supplementation.	L- Carnitine	Patients with drug resistant epilepsy who received ketogenic diet with L - Carnitine supplementation.
ketogenic diet.	ketogenic diet	Patients with drug resistant epilepsy who received ketogenic diet only.
ketogenic diet with L - Carnitine supplementation.	ketogenic diet	Patients with drug resistant epilepsy who received ketogenic diet with L - Carnitine supplementation.

Primary Outcome Measures

Name	Time	Method
Assessment the effect of L-carnitine supplementation on gastric emptying in children with drug resistant epilepsy (DRE) on ketogenic diet (KD).	At time of enrollment and 3 months of intervention.	Antral length measurement using abdominal ultrasonography.

Trial Locations

Locations (1)

Faculty of Medicine-Ain Shams University; 🇪🇬 Cairo, Abbasia, Egypt