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临床试验/NCT06198803
NCT06198803进行中(未招募)早期 1 期

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

Ain Shams University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2022年1月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
进行中(未招募)
入组人数
52
试验地点
1
主要终点
The Effect of Carnitine Supplementation on systolic and diastolic functions in Patients With Drug Resistant Epilepsy on Ketogenic Diet

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Participant)

盲法说明

Patients who are already on KD and carnitine supplements.

入排标准

年龄范围
1 Month 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Patients who are already on KD and carnitine supplements.

研究组 & 干预措施

l carnitine group

Experimental

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

干预措施: L Carnitine (Drug)

结局指标

主要结局

The Effect of Carnitine Supplementation on systolic and diastolic functions in Patients With Drug Resistant Epilepsy on Ketogenic Diet

时间窗: 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

The Effect of Carnitine supplementation on serum triglycerides, cholesterol, LDL and HDL in lipid profile in Patients With Drug Resistant Epilepsy on Ketogenic Diet

时间窗: 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

The Effect of Carnitine supplementation on Convulsions in Patients With Drug Resistant Epilepsy on Ketogenic Diet

时间窗: baseline

the effect of carnitine supplementation on chalfont seizure severity scale to assess convulsions in patients with drug resistant epilepsy on ketogenic diet

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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