- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06198803
The Effect of Carnitine Supplementation on Cardiac Function and Lipid Profile in Patients With Drug Resistant Epilepsy on Ketogenic Diet
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Cairo
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: l carnitine group
All aged from 1 month till 16 years old with DRE on KD.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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
|
baseline
|
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
|
baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- carnitine effect on cardiac
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on l Carnitine With Ketogenic Diet
-
University of VirginiaTerminatedExercise | Ketogenic DietUnited States
-
University of VirginiaTerminatedKidney Injury | Ketogenic DietUnited States
-
Beth Israel Deaconess Medical CenterCompletedFasting | Ketogenic Diet | Metabolic RegulationUnited States
-
National Taiwan University HospitalRecruitingGut Dysbiosis for TMAO Production From L-carnitine ConsumptionTaiwan
-
Poznan University of Life SciencesPoznan University of PhysEDUnknownNutrition | Ketogenic Dieting | Sport | Low Glycemic Index Diet | CrossfitPoland
-
Baoling GuoNot yet recruitingKetogenic Diet
-
Ain Shams UniversityCompleted
-
Duke UniversityUnited States Department of DefenseCompletedCNS Oxygen Toxicity, Ketogenic DietUnited States
-
University of British ColumbiaCompleted
-
Number 2 Children's Hospital, Ho Chi Minh CityCompletedFeasibility | Children | Efficacy | Drug Resistant Epilepsy | Tolerability | Ketogenic DietVietnam
Clinical Trials on L Carnitine
-
Gdansk University of Physical Education and SportMedical University of GdanskCompleted
-
Gdansk University of Physical Education and SportMedical University of GdanskCompleted
-
Ain Shams UniversityCompleted
-
Vanderbilt University Medical CenterCompletedLung Diseases | Pulmonary Arterial Hypertension | Familial Primary Pulmonary Hypertension | Primary Pulmonary Hypertension | Carnitine Nutritional DeficiencyUnited States
-
Toujinkai HospitalCompletedDisorder of Fatty Acid Metabolism
-
Bahria UniversityUniversity of Karachi; Jinnah Postgraduate Medical Centre; Pakistan Navy Station...RecruitingHemodialysis ComplicationPakistan
-
HealthPartners InstituteTerminatedBreast Cancer | Neurotoxicity | Chemotherapeutic Agent ToxicityUnited States
-
National Taiwan University HospitalRecruitingGut Dysbiosis for TMAO Production From L-carnitine ConsumptionTaiwan
-
Heba Allah Ali Abd El-Halim MabroukTanta UniversityCompleted
-
Kochi UniversityUnknown