The Effect of Carnitine Supplementation on Cardiac Function and Lipid Profile in Patients With Drug Resistant Epilepsy on Ketogenic Diet

NCT ID: NCT06198803

Last Updated: 2024-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-03
• Study Completion Date: 2024-07-31

Brief Summary

Primary aim: Demonstrating the effect of carnitine supplementation on lipid profile and cardiovascular functions in patients with DRE on KD.

Secondary aim: To highlight the effect of carnitine supplementation on efficacy of KD in seizure control.

Detailed Description

The KD, a strict diet high in fat and low in carbohydrates, increases the ketone body concentrations that could lead to an enhancement of inhibitory neurotransmission and thereby possibly reducing the seizure frequency (Seo et al., 2007).

Carnitine plays a major role in the degradation of fatty acids. As a trimethylated amino acid, it facilitates translocation of fatty acids into the mitochondrion and is therefore an essential cofactor in fatty acid oxidation and ketogenesis (Longo et al., 2016).

Carnitine transports dietary fat to the mitochondria to be oxidized into ketones, which are used for energy when sufficient carbohydrate is not available (Coppola et al., 2006; Mcnally & Hartman, 2012).

Levocarnitine can improve cardiac function effectively through improving albumin, high sensitivity CRP, Brain natriuretic protein, troponin, and left ventricular end diastolic dimension (Zhao et al., 2020).

Due to the high fat intake, children following KD may have an increased demand for carnitine and therefore, may be at an increased risk for carnitine deficiency (Neal EG et al.,2008).

Although total carnitine decrease over the first few months of KD treatment, and in some patients, dip into the deficiency range, it then normalizes with no evidence of a continued decline (Berry-Kravis et al., 2001; Coppola et al., 2006).

Few studies was performed to evaluate carnitine effect in epileptic children and adolescents treated with old and new antiepileptic drugs with or without ketogenic diet Coppola et al., 2006).

The KD is mostly associated with Gastrointestinal (GI) disturbances, such as nausea, vomiting, diarrhea, and constipation, also were frequently noted, sometimes associated with gastritis and fat intolerance (Armeno et al., 2018).

Conditions

l Carnitine With Ketogenic Diet

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

l carnitine group

All aged from 1 month till 16 years old with DRE on KD.

Group Type: EXPERIMENTAL

L Carnitine

Intervention Type: DRUG

The study population will be randomly divided into 2 groups, 1 group will receive Carnitine supplementation in a dose of 100mg/kg/day

non l carnitine gruop

patient with drug resistant epilepsy on ketogenic diet

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

L Carnitine

The study population will be randomly divided into 2 groups, 1 group will receive Carnitine supplementation in a dose of 100mg/kg/day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• All aged from 1 month till 16 years old with DRE on KD.

Exclusion Criteria

• Patients who are already on KD and carnitine supplements.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cairo

Cairo, , Egypt

Countries

Egypt

Other Identifiers

carnitine effect on cardiac

Identifier Type: -

Identifier Source: org_study_id