Oral L-carnitine and Inflammatory and Nutritional Biomarkers in Maintenance Hemodialysis
NCT ID: NCT07249229
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2020-11-30
2021-03-08
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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L-carnitine Group
Patients received oral L-carnitine solution (1 g), administered three times per week immediately after each hemodialysis session for 3 months.
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 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.
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Darya Chamani
OTHER
Responsible Party
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Darya Chamani
Pharm.D., Principal Investigator
Locations
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Bu Ali Hospital
Tehran, Tehran Province, Iran
Countries
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Other Identifiers
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LC-HD-IAU-2020
Identifier Type: -
Identifier Source: org_study_id