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

What Was Tested

This registered phase 2 trial tested L-Carnitine.

The study will last for three months.

It had two arms (groups): L-carnitine Group (experimental) and 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.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

The registry lists 50 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this L-Carnitine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The L-Carnitine group and the comparison group ran side by side rather than switching.

As a double-blind L-Carnitine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2020-11-30 with completion listed for 2021-02-28.

It ran at 1 site in Iran.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: hs-CRP levels (high sensitivity C-reactive protein) (time frame: Baseline and at 3 months after the start of intervention).

It also tracked 3 secondary outcomes, for example Lipid profile (total cholesterol, LDL, HDL, triglycerides), Ferritin levels and Serum albumin levels.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of L-Carnitine in 50 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the L-Carnitine compound page, all human trials.