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

NCT ID: NCT06255873

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-20
• Study Completion Date: 2023-11-15

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.

Conditions

Ketogenic Diet

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ketogenic diet with L - Carnitine supplementation.

Patients with drug resistant epilepsy who received ketogenic diet with L - Carnitine supplementation.

Group Type: EXPERIMENTAL

L- Carnitine

Intervention Type: DIETARY_SUPPLEMENT

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.

ketogenic diet

Intervention Type: OTHER

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.

ketogenic diet.

Patients with drug resistant epilepsy who received ketogenic diet only.

Group Type: ACTIVE_COMPARATOR

ketogenic diet

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Haya Essam Ibrahim

lecturer of pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

May F Nassar, MD

Role: STUDY_DIRECTOR

Professor of pediatrics, Faculty of Medicine, Ain shams University

Locations

Faculty of Medicine-Ain Shams University

Cairo, Abbasia, Egypt

Countries

Egypt

Other Identifiers

FMASU MS 630/ 2022

Identifier Type: -

Identifier Source: org_study_id