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

NCT07249229 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-19

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Darya Chamani

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-30
Primary Completion
2021-02-28
Completion
2021-03-08

Countries

  • Iran

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07249229 on ClinicalTrials.gov