NCT07249229

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

Investigating the Effect of Oral L-Carnitine on Inflammatory and Nutritional Factors in Patients With Advanced Kidney Failure Undergoing Chronic Hemodialysis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Darya Chamani · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• End-stage Renal Disease (ESRD)
• Hemodialysis

Interventions

Type	Name	Description
DRUG	L-carnitine 1000 Mg	Participants assigned to the intervention arm received L-carnitine oral solution (1 g) administered three times per week immediately after each hemodialysis session for a total duration of 3 months. The oral solution was provided in identical packaging and labeling as placebo to ensure double blinding.
DRUG	Placebo	Participants assigned to the placebo arm received an oral placebo solution consisting of distilled water and sodium saccharin, three times weekly immediately post-hemodialysis for 3 months, matched to the active formulation in appearance, packaging, and labeling.

Timeline

• Start date: 2020-11-30
• Primary completion: 2021-02-28
• Completion: 2021-03-08
• First posted: 2025-11-25
• Last updated: 2025-12-19

Locations

1 site across 1 country: Iran