Carnitine Supplementation in Pediatric Hemodialysis Patients

What Was Tested

The trial (early phase 1) is built around L-Carnitine.

The goal of this study is: 1.

To determine the prevalence of carnitine deficiency among pediatric patients on hemodialysis. 2.

To evaluate the efficiency of carnitine supplementation in children on regular hemodialysis with carnitine deficiency in the treatment of renal anemia, cardiac dysfunction, dyslipidemia, intradialytic muscle cramps and hypotension and their quality of life.

It had two arms (groups): L-Carnitine Group (experimental) and Placebo Group (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

In addition, accumulating evidence has linked inflammation to malnutrition, and chronic inflammation might also interrupt carnitine transfer in the intestine.

As in the healthy population, carnitine deficiency in patients receiving maintenance dialysis is most commonly defined as a serum free carnitine level less than 20 μmol/L .

Who Took Part

Enrollment: 40 planned participants were the target.

It was open to people of any sex aged up to 16 years.

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

Examples of who could join: All patients on regular hemodialysis for more than three months with L-carnitine deficiency. Recurrent intradialytic complications (cramping, muscular pain, hypotension). Sex: both males and females. Age: 16 years old or less.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: patients known to be allergic to l-carnitine; patients with inborn error of metabolism; patients on lipid lowering therapy.

How the Study Was Run

The set-up was randomized, parallel-group and triple-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.

Blinding on both sides kept the participants and researchers unaware of who received L-Carnitine.

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

It started in 2023-08-01 with completion listed for 2024-02-01.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: change in serum free carnitine level (time frame: before supplementation and after six months of supplementation). change in cardiac functions (time frame: before supplementation and after six months of supplementation). change in hemoglobin level (time frame: before supplementation and after six months of supplementation).

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of L-Carnitine in 40 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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