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

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.

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Key information

Conditions

Ketogenic Diet

Age range

12 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine-Ain Shams University

Cairo, Abbasia, 1181, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

Assessment the effect of L-carnitine supplementation on gastric emptying in children with drug resistant epilepsy (DRE) on ketogenic diet (KD).

Time frame: At time of enrollment and 3 months of intervention.

Antral length measurement using abdominal ultrasonography.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Feb 13, 2024
Registry last updated: Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed