L-Carnitine as an Adjuvant Treatment in Acute Phosphide Poisoning (LC)

What Was Tested

In this early phase 1 trial, researchers set out to test L-Carnitine.

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

The registry classes the interventions as drug.

More on the Plan

A written informed consent was taken from each patient or his/her guardians (if the patient was unable to participate in the consent process).

Confidentiality of the data was maintained by making code numbers for each patient.

Fifty patients was randomized to LC or a non LC in a 1:1 ratio (25 patients in each group).

Patients was monitored and a detailed documentation of any adverse effect due to LC therapy was recorded.

Who Took Part

Enrollment: 50 actual participants took part.

It was open to people of any sex aged from 12 years with no upper age limit.

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

Examples of who could join: Patients (male or female, aged 12 years or older) with symptomatic acute phosphide poisoning (deliberate or accidental), with diagnosis made on the basis of:.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: patients less than 12 years of age pregnant and lactating women patients with ingestion or exposure to other substances in addition to phosphide.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got L-Carnitine and who got the comparison, which limits bias.

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

In this single-blind L-Carnitine study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2016-01 with completion listed for 2018-01.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Mortality (time frame: 2 years).

It also tracked 1 secondary outcome, for example Duration of hospital stay.

What This Means in Plain Language

Put simply, this is a early phase 1, 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.