L-Carnitine Supplementation, Rate of Weight Gain and EED in Children With SAM

What Was Tested

This registered not phased trial tested L-Carnitine.

It had two arms (groups): Intervention Arm (active comparator) and Control Arm (placebo comparator).

The registry classes the interventions as drug and other.

More on the Plan

Study Design: Study Site: This study will be done in the Dhaka Hospital at icddr,b.

Study population: In this study, the investigator will enroll diarrheal children with SAM aged 9-24 months of both genders attending longer stay units (LSU).

If the parent(s) are interested in volunteering in the study, the designated staff will proceed to consent consisting of a thorough review of the written consent form in a manner appropriate for the child's parents' literacy level.

Prior to signing the consent form, parent(s) will have an opportunity to ask any questions about the study participants fulfilling the eligibility criteria will be brought to the study physician for clinical assessment.

Who Took Part

The registry lists 98 actual participants took part.

It was open to people of any sex aged from 9 months up to 24 months.

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

Examples of who could join: Diarrheal children with SAM aged 9-24 months. Signed informed consent by the guardian/caregivers.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: severe sepsis or septic shock; patients already taking medications containing l- carnitine; children with tuberculosis.

How the Study Was Run

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

It started in 2021-10-19 with completion listed for 2023-03-30.

It ran at 1 site in Bangladesh.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Rate of weight gain (time frame: Baseline to 15th day of treatment).

It also tracked 2 secondary outcomes, for example Duration of hospital stays and EED biomarkers [myeloperoxidase (MPO), neopterin (NEO), alpha-1 anti-trypsin (A1AT), kynurenine: tryptophan (KT) ratio, and citrulline].

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of L-Carnitine in 98 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.