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

NCT06198803 | Unknown Early Phase 1

• 1 other identifier: carnitine effect on cardiac
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

l Carnitine With Ketogenic Diet

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  baseline

Study Arms (2)

l carnitine group

EXPERIMENTAL

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

Drug: L Carnitine

non l carnitine gruop

NO INTERVENTION

patient with drug resistant epilepsy on ketogenic diet

Interventions

L Carnitine DRUG

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

l carnitine group

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Patients who are already on KD and carnitine supplements.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Cairo

Cairo, Egypt

Location

MeSH Terms

Interventions

Carnitine

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients who are already on KD and carnitine supplements.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: January 10, 2024
• Study Start: January 3, 2022
• Primary Completion: January 1, 2024
• Study Completion: July 1, 2024
• Last Updated: January 10, 2024

Record last verified: 2023-10

Locations

EG (1)