End-stage Renal Disease (ESRD), Hemodialysis
Conditions
Keywords
L-carnitine, Hemodialysis, End-stage renal disease, Inflammation, Malnutrition, hs-CRP, Albumin, Ferritin, Lipid profile
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.
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.
Interventions
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.
DRUGPlacebo
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
Darya Chamani
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hs-CRP levels (high sensitivity C-reactive protein) | Baseline and at 3 months after the start of intervention | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lipid profile (total cholesterol, LDL, HDL, triglycerides) | Baseline and at 3 months after the start of intervention | Change in lipid profile parameters from baseline to 3 months to assess metabolic impact of L-carnitine |
| Ferritin levels | Baseline and at 3 months after the start of intervention | Change in serum ferritin levels from baseline to 3 months as a marker of iron status and inflammation |
| Serum albumin levels | Baseline and at 3 months after the start of intervention | Change in serum albumin concentration from baseline to 3 months as an indicator of nutritional status |
Countries
Iran
Outcome results
None listed