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

NCT06255873 | Completed

• 1 other identifier: FMASU MS 630/ 2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

ketogenic diet with L - Carnitine supplementation.

EXPERIMENTAL

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

Dietary Supplement: L- Carnitine; Other: ketogenic diet

ketogenic diet.

ACTIVE COMPARATOR

Patients with drug resistant epilepsy who received ketogenic diet only.

Other: ketogenic diet

Interventions

L- Carnitine 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 with L - Carnitine supplementation.

ketogenic diet 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 with L - Carnitine supplementation.; ketogenic diet.

Eligibility Criteria

• Age: 12 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine-Ain Shams University

Cairo, Abbasia, 1181, Egypt

Location

MeSH Terms

Interventions

Carnitine; Diet, Ketogenic

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• May F Nassar, MD

  Professor of pediatrics, Faculty of Medicine, Ain shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of pediatrics

Study Record Dates

• First Submitted: February 3, 2024
• First Posted: February 13, 2024
• Study Start: January 20, 2023
• Primary Completion: September 22, 2023
• Study Completion: November 15, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

EG (1)