Clinical trial NCT06198803: The Effect of Carnitine Supplementation on Cardiac Function and Lipid Profile in Patients With Drug Resistant Epilepsy on Ketogenic Diet
Official title: The Effect of Carnitine Supplementation on Cardiac Function and Lipid Profile in Patients With Drug Resistant Epilepsy on Ketogenic Diet
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: l Carnitine With Ketogenic Diet
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 52
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All aged from 1 month till 16 years old with DRE on KD.
Primary purpose: SCREENING

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).

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.

Primary outcomes:
measure: The Effect of Carnitine Supplementation on systolic and diastolic functions in Patients With Drug Resistant Epilepsy on Ketogenic Diet
timeFrame: baseline
measure: The Effect of Carnitine supplementation on serum triglycerides, cholesterol, LDL and HDL in lipid profile in Patients With Drug Resistant Epilepsy on Ketogenic Diet
timeFrame: baseline
measure: The Effect of Carnitine supplementation on Convulsions in Patients With Drug Resistant Epilepsy on Ketogenic Diet
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo
Study officials:
References: