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

• ClinicalTrials.gov Identifier: NCT06198803
• Recruitment Status: Active, not recruiting
• First Posted: January 10, 2024
• Last Update Posted: January 10, 2024
• Sponsor: Ain Shams University
• Information provided by (Responsible Party): Ain Shams University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
l Carnitine With Ketogenic Diet	Drug: L Carnitine	Early Phase 1

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: All aged from 1 month till 16 years old with DRE on KD.
• Masking: Single (Participant)
• Masking Description: Patients who are already on KD and carnitine supplements.
• Primary Purpose: Screening
• Official Title: The Effect of Carnitine Supplementation on Cardiac Function and Lipid Profile in Patients With Drug Resistant Epilepsy on Ketogenic Diet
• Actual Study Start Date: January 3, 2022
• Estimated Primary Completion Date: January 2024
• Estimated Study Completion Date: July 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: l carnitine group; All aged from 1 month till 16 years old with DRE on KD.	Drug: 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
No Intervention: non l carnitine gruop; patient with drug resistant epilepsy on ketogenic diet

Outcome Measures

Primary Outcome Measures :

1. The Effect of Carnitine Supplementation on systolic and diastolic functions in Patients With Drug Resistant Epilepsy on Ketogenic Diet [ Time Frame: baseline ]
   Demonstrate The effect of carnitine supplementation on Ejection Fraction to assess systolic and E/A ratio to assess diastolic functions in patients with drug resistant epilepsy on Ketogenic Diet
2. The Effect of Carnitine supplementation on serum triglycerides, cholesterol, LDL and HDL in lipid profile in Patients With Drug Resistant Epilepsy on Ketogenic Diet [ Time Frame: baseline ]
   the effect of carnitine supplementation on serum triglycerides in milligrams per deciliter, cholesterol in milligrams per deciliter, LDLin milligrams per deciliter and HDL in milligrams per deciliter in lipid profile in patients with drug resistant epilepsy on ketogenic diet
3. The Effect of Carnitine supplementation on Convulsions in Patients With Drug Resistant Epilepsy on Ketogenic Diet [ Time Frame: baseline ]
   the effect of carnitine supplementation on chalfont seizure severity scale to assess convulsions in patients with drug resistant epilepsy on ketogenic diet

Eligibility Criteria

• Ages Eligible for Study: 1 Month to 16 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Egypt

Cairo

Cairo, Egypt

Sponsors and Collaborators

Ain Shams University

More Information

• Responsible Party: Ain Shams University
• ClinicalTrials.gov Identifier: NCT06198803
• Other Study ID Numbers: carnitine effect on cardiac
• First Posted: January 10, 2024
• Last Update Posted: January 10, 2024
• Last Verified: October 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Epilepsy; Drug Resistant Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases