Investigating the Effect of Oral L-Carnitine on Inflammatory and Nutritional Factors in Patients With Advanced Kidney Failure Undergoing Chronic Hemodialysis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- hs-CRP levels (high sensitivity C-reactive protein)
研究概览
简要总结
The goal of this clinical trial is to evaluate whether oral L-carnitine supplementation helps reduce inflammation and improve nutritional status in patients with end-stage kidney disease who are undergoing long-term hemodialysis.
A total of 50 participants will be randomly assigned to receive either:
- Oral L-carnitine solution (1 g, three times per week after dialysis), or
- A placebo solution that looks and tastes the same but does not contain L-carnitine.
The study will last for three months. Researchers will assess changes in:
- Inflammatory markers (high-sensitivity C-reactive protein, hs-CRP)
- Nutritional markers (serum albumin, ferritin)
- Blood lipid profile (cholesterol, LDL, HDL, triglycerides)
The findings from this study are expected to provide insights into the potential clinical benefits of oral L-carnitine supplementation in maintenance hemodialysis patients.
详细描述
This randomized, quadruple-blind, placebo-controlled clinical trial is designed to investigate the effect of oral L-carnitine supplementation on inflammatory and nutritional parameters in patients with end-stage renal disease (ESRD) undergoing chronic hemodialysis (HD).
Study Design and Participants:
The study is conducted at the dialysis departments of Bu Ali Hospital and Partian Clinic in Tehran. Eligible participants are adults (≥18 years) who have been on maintenance HD for at least 6 months, are clinically stable for at least 3 months, and are able to provide informed consent. Patients are excluded if they have a recent infection, malignancy, severe liver disease, uncontrolled comorbidities, or have used anti-inflammatory or lipid-lowering drugs within the previous 3 months.
Randomization and Intervention:
Fifty participants are randomized into two groups. The intervention group receives oral L-carnitine solution (1 g, three times per week after dialysis, produced by Bonyan Salamat Kasra Company). The control group receives a placebo solution (distilled water with sodium saccharin) identical in appearance and packaging. Randomization is computer-generated and allocation is concealed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •On maintenance hemodialysis for at least 6 months
- •Clinically stable for ≥ 3 months
- •No hospitalization in the preceding 3 months
- •Willingness to provide written informed consent and comply with study procedures
排除标准
- •Use of statins, erythropoietin, corticosteroids, NSAIDs, or other anti-inflammatory/lipid-lowering agents within the previous 3 months
- •Active infection, inflammatory disease, malignancy, or severe hepatic dysfunction
- •Pregnancy or breastfeeding
- •Participation in another clinical trial within the preceding 3 months
- •Uncontrolled comorbidities (e.g., uncontrolled diabetes or hypertension)
- •Acute cardiovascular events within the past 6 months
- •Planned kidney transplantation during the study period
- •Anticipated poor compliance
- •Use of medications that could affect inflammatory or lipid parameters
- •History of hypersensitivity to L-carnitine
研究组 & 干预措施
L-carnitine Group
Patients received oral L-carnitine solution (1 g), administered three times per week immediately after each hemodialysis session for 3 months.
干预措施: L-carnitine 1000 Mg (Drug)
Placebo Group
Patients received placebo solution (distilled water and sodium saccharin), identical in appearance, packaging, and labeling to the active formulation, administered three times per week immediately after each hemodialysis session for 3 months.
干预措施: Placebo (Drug)
结局指标
主要结局
hs-CRP levels (high sensitivity C-reactive protein)
时间窗: Baseline and at 3 months after the start of intervention
Change in serum hs-CRP levels from baseline to 3 months of treatment. hs-CRP will be measured to evaluate systemic inflammation and assess the anti-inflammatory effect of oral L-carnitine supplementation compared with placebo in patients undergoing hemodialysis
次要结局
- Lipid profile (total cholesterol, LDL, HDL, triglycerides)(Baseline and at 3 months after the start of intervention)
- Ferritin levels(Baseline and at 3 months after the start of intervention)
- Serum albumin levels(Baseline and at 3 months after the start of intervention)
研究者
Darya Chamani
Pharm.D., Principal Investigator
Tehran Islamic Azad University of Medical Sciences