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

Ketogenic Diet Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06255873
• Other study ID #: FMASU MS 630/ 2022
• Status: Completed
• Phase: N/A
• Start date: January 20, 2023
• Est. completion date: November 15, 2023

Study information

• Verified date: February 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 15, 2023
• Est. primary completion date: September 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy
• Ketogenic Diet

Intervention

Dietary Supplement:
• L- Carnitine
L-carnitine was taken after feeds in the form of tablets or dissolved tablets in a dose of 50 mg/kg/day, with maximum dose of 2 g/day.

Other:
• ketogenic diet
ketogenic diet (KD) initiated under supervision of expert physician who considered patient's age, type of feeding, needs and preferences of the child and his/her family to select the type and initial ratio of KD therapy, KD ratio ranged from 1:1 to 4:1 of lipids to carbohydrates plus proteins in grams.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine-Ain Shams University	Cairo	Abbasia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

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