Impact of Hemodialysis on Plasma Carnitine Levels in Patients With End Stage Renal Disease

What Was Tested

This registered phase 2, phase 3 trial tested L-Carnitine.

OBJECTIVES * To assess the levels of plasma carnitine in controls and hemodialysis patients. * To give supplementary L-carnitine to study subjects for a duration of 5months. * To compare the values of plasma carnitine before and after L carnitine supplementation. * To assess the role of carnitine supplementation on biochemical and clinical parameters.

It had two arms (groups): intervention (experimental) and control (no intervention).

No intervention given.

The registry classes the interventions as drug.

More on the Plan

A positive correlation between AC/FC ratio and months on HD therapy has been reported.

The researchers investigate in this study the role of oral L-carnitine supplementation on anemia, blood pressure, cardiac dysfunction and muscle cramps in hemodialysis patients.

METHOD: Total 120 subjects will be included in this study which will be divided into two groups.

Group A will comprise of 60 subjects of Chronic renal failure who will be the control group.

Who Took Part

The registry lists 83 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: The study included people between the ages of 18 and 50 who had had dialysis for more than two years without taking additional antioxidants.

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: • individuals with any other chronic ailment, such as cancer or tuberculosis; patients with acute renal failure who are receiving hemodialysis; all subjects who refused to take part in the investigation.

How the Study Was Run

Design: non-randomized, single-group and open-label.

Nothing was hidden in this open-label L-Carnitine study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2023-01-01 with completion listed for 2023-07-02.

It ran at 1 site in Pakistan.

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main measure: L-Carnitine levels in hemodialysis (time frame: 5 months).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, non-randomized trial of L-Carnitine in 83 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.