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

NCT07249229 | Completed Phase 2

• 1 other identifier: LC-HD-IAU-2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

End-stage Renal Disease (ESRD); Hemodialysis

Keywords

L-carnitine; Hemodialysis; End-stage renal disease; Inflammation; Malnutrition; hs-CRP; Albumin; Ferritin; Lipid profile

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

L-carnitine Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

L-carnitine 1000 Mg DRUG

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.

L-carnitine Group

Placebo DRUG

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.

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Darya Chamani: lead

Study Sites (1)

Bu Ali Hospital

Tehran, Tehran Province, 1711734365, Iran

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Inflammation; Malnutrition

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pharm.D., Principal Investigator

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: November 25, 2025
• Study Start: November 30, 2020
• Primary Completion: February 28, 2021
• Study Completion: March 8, 2021
• Last Updated: December 19, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)