L-carnitine on the Prevention of Renal Scarring in Acute Pyelonephritis

What Was Tested

In this phase 3 trial, researchers set out to test L-Carnitine.

Risk factors for parenchymal damage in urinary tract infection are vesicoureteral reflux (VUR),obstructive uropathy,the number of flares of acute pyelonephritis(APN) and delay in treatment of acute infection.The pathogenesis of APN is related to bacterial virulenece,immune response,tissue factors,apoptosis and production of free radicals that lead to fibrosis and renal scarring.

It had two arms (groups): L-carnitine (active comparator) and Control (no intervention).

Control group received just antibiotic regimens without L-carnitine.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 78 planned participants were the target.

It was open to people of any sex aged from 1 Month up to 10 years.

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

Examples of who could join: Children aged 1 month to 10 years with positive urine culture, clinical findings, and 99mTc-dimercaptosuccinic acid (DMSA) scintigraphy-based evidence in favor of acute pyelonephritis.

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: neurogenic bladder,; systemic hypertension,; obstructive uropathy.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

The participants were allocated by chance, so the L-Carnitine group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether L-Carnitine was given.

Those kept unaware of assignments: participant.

It started in 2013-11 with completion listed for 2014-08.

It ran at 1 site in Iran.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Development of renal scar by doing DMSA renal scan (time frame: Seven and six months after the intervention).

It also tracked 1 secondary outcome, for example Severity of pyelonephritis and response to treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of L-Carnitine in 78 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.