The Possible Efficacy and Safety of L-carnitine and Biotin as Adjunctive Therapies in Children With Moderate Persistent Asthma

What Was Tested

The trial (phase 3) is built around L-Carnitine.

It had three arms (groups): Placebo (placebo comparator), L-carnitine (experimental) and Biotin (experimental).

Group 1 (n=22) which will receive traditional therapy plus placebo capsule twice daily for 3 months.

The registry classes the interventions as drug.

Who Took Part

66 planned participants were the target.

It was open to people of any sex aged from 8 years up to 18 years.

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

Examples of who could join: Children with moderate persistent asthma. Age range of 8-\< 18 years old.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: children with any pulmonary or chronic systemic diseases other than asthma (cystic fibrosis, bronchiectasis, tuberculosis, diabetes mellitus, and liver disease); children with immunodeficiency; children with thyroid disorder.

How the Study Was Run

The set-up was 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.

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

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

Those kept unaware of assignments: outcomes assessor.

It started in 2022-08-08 with completion listed for 2024-08-08.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Pulmonary function test (PFT) (time frame: 3 months). Childhood asthma control test (C-ACT) (time frame: 3 months).

It also tracked 3 secondary outcomes, for example serum levels of TGF-β1, serum levels of TNF-α and serum levels of 8-OHDG.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of L-Carnitine in 66 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.