Oral L-carnitine and Inflammatory and Nutritional Biomarkers in Maintenance Hemodialysis

Darya Chamani

Status and phase: Completed; Phase 2

Conditions: Hemodialysis; End-stage Renal Disease (ESRD)

Treatments: Drug: L-carnitine 1000 Mg; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07249229

LC-HD-IAU-2020

Details and patient eligibility

About

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.

Full description

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.

Endpoints:

The primary outcome measure is the change in high-sensitivity C-reactive protein (hs-CRP) after three months of intervention. Secondary outcome measures include changes in serum albumin, ferritin, triglycerides, total cholesterol, HDL, and LDL.

This study is intended to help determine whether oral L-carnitine supplementation can improve inflammation, nutritional status, and lipid metabolism in hemodialysis patients.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

L-carnitine Group

Experimental group

Description:

Patients received oral L-carnitine solution (1 g), administered three times per week immediately after each hemodialysis session for 3 months.

Treatment:

Drug: L-carnitine 1000 Mg

Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo