Effects of Parenteral L-carnitine Supplementation in Premature Neonates

What Was Tested

This registered not phased trial tested L-Carnitine.

Background: Carnitine is the essential cofactor for various enzyme activities of human metabolism, especially for the mitochondrial carnitine shuttle that transfers long-chain fatty acids as acylcarnitine esters across the inner mitochondrial membrane for Beta-oxidation and energy production.

Intracellular carnitine deficiency induces an impairment of long-chain fatty acid oxidation.

It had two arms (groups): Carnitine (experimental) and Controle (placebo comparator).

Intervention 'Parenteral supplementation with sterile water'.

The registry classes the interventions as drug.

More on the Plan

Primary Outcome: Plasma Gamma Glutamyl Transferase level after 21 days of parenteral supplementation.

Who Took Part

53 actual participants took part.

It was open to people of any sex aged up to 28 Weeks.

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

Examples of who could join: Premature newborn admitted in Intensive Care Unit,. Gestational age minor or equal than 28 weeks and 6 days,. Needing prolonged parenteral nutrition through a central intravenous catheter,. Parenteral nutrition started before 6 days of life,. Both parents (or legal tutor) gave written informed consent for their children,.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: identified genetic disease,; polymalformative syndrome, or severe malformation (heart, brain, others…),; inborn error of metabolism,.

How the Study Was Run

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

Neither the participants nor the staff measuring them knew who was on L-Carnitine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2008-07 with completion listed for 2013-03.

It ran at 2 sites in France (2).

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Plasma Gamma Glutamyl Transferase level (time frame: After 21 days of parenteral supplementation).

It also tracked 6 secondary outcomes, for example Liver function: levels of ammonemia, hyaluronic acid, bilirubin, prothrombin time test, use of ursodeoxycholic acid therapy, Cardiac function: echocardiography, EKG, Muscle integrity: CK levels, Neurological injuries: brain ultrasound and MRI, Respiratory immaturity and Acylcarnitine profile, and other fatty acid derivative levels.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 53 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.