An Early Phase 1 interventional study of L Carnitine in l Carnitine With Ketogenic Diet, sponsored by Ain Shams University. Active, not recruiting at 1 site in Egypt. Open to participants aged 1 Month to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-10.
Sponsored by Ain Shams University · Early Phase 1, Interventional, and Screening
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.
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).
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
This study's planned enrollment of 52 is close to the median of 50 across 1,206 interventional studies indexed under Epilepsy.
Browse Epilepsy studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
All aged from 1 month till 16 years old with DRE on KD.
Drug: L Carnitine
patient with drug resistant epilepsy on ketogenic diet
The study population will be randomly divided into 2 groups, 1 group will receive Carnitine supplementation in a dose of 100mg/kg/day
The Effect of Carnitine Supplementation on systolic and diastolic functions in Patients With Drug Resistant Epilepsy on Ketogenic Diet
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
Time frame: baseline
The Effect of Carnitine supplementation on serum triglycerides, cholesterol, LDL and HDL in lipid profile in Patients With Drug Resistant Epilepsy on Ketogenic Diet
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
Time frame: baseline
The Effect of Carnitine supplementation on Convulsions in Patients With Drug Resistant Epilepsy on Ketogenic Diet
the effect of carnitine supplementation on chalfont seizure severity scale to assess convulsions in patients with drug resistant epilepsy on ketogenic diet
Time frame: baseline
This study is active, not recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Ain Shams University