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

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis; End-stage Renal Disease (ESRD)
• Intervention / Treatment: Drug: L-carnitine 1000 Mg; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Iran
  • Tehran Province
    • Tehran, Tehran Province, Iran, 1711734365
      • Bu Ali Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: L-carnitine Group; Patients received oral L-carnitine solution (1 g), administered three times per week immediately after each hemodialysis session for 3 months.	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.
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hs-CRP levels (high sensitivity C-reactive protein)	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	Baseline and at 3 months after the start of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid profile (total cholesterol, LDL, HDL, triglycerides)	Change in lipid profile parameters from baseline to 3 months to assess metabolic impact of L-carnitine	Baseline and at 3 months after the start of intervention
Ferritin levels	Change in serum ferritin levels from baseline to 3 months as a marker of iron status and inflammation	Baseline and at 3 months after the start of intervention
Serum albumin levels	Change in serum albumin concentration from baseline to 3 months as an indicator of nutritional status	Baseline and at 3 months after the start of intervention

Collaborators and Investigators

• Sponsor: Darya Chamani

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2020
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): March 8, 2021

Study Registration Dates

• First Submitted: October 1, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Estimated): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Inflammation; End-stage renal disease; L-carnitine; Hemodialysis; Malnutrition; Lipid profile; Ferritin; Albumin; hs-CRP
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Nutrition Disorders; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Malnutrition; Inflammation; Kidney Failure, Chronic; Organic Chemicals; Amines; Quaternary Ammonium Compounds; Trimethyl Ammonium Compounds; Carnitine
• Other Study ID Numbers: LC-HD-IAU-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared due to patient privacy concerns, ethical considerations, and institutional restrictions. Only aggregated results will be published in peer-reviewed journals

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No