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

NCT05632549 | Unknown Phase 3

• 1 other identifier: 35652/8/22
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Moderate Persistent Asthma

Outcome Measures

Primary Outcomes (2)

• Pulmonary function test (PFT)

  Pulmonary Function Test (PFT) using a calibrated computerized spirometer. Subjects will be submitted to 3 acceptable Forced Vital Capacity (FVC) maneuvers according to American Thoracic Society recommendations (NIH, 2007). The maximum percentage in Forced Expiratory Volume in 1 second (FEV1) value from 3 readings will be calculated.

  3 months

• Childhood asthma control test (C-ACT)

  Childhood-Asthma Control Test (C-ACT) is a 7-item child- and caregiver-completed tool with a scoring range of 0-27. The higher scores indicate better control. A score of 19 or less indicates that the asthma is not well controlled.

  3 months

Secondary Outcomes (3)

• serum levels of TGF-β1

  at baseline and 3 months after intervention

• serum levels of TNF-α

  at baseline and 3 months after intervention

• serum levels of 8-OHDG

  at baseline and 3 months after intervention

Study Arms (3)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

L-carnitine

EXPERIMENTAL

Group 2 (n=22) which will receive traditional therapy plus L-carnitine capsules (500 mg twice daily) for 3 months.

Drug: L-Carnitine 500Mg Oral Tablet

Biotin

EXPERIMENTAL

Group 3 (n=22) which will receive traditional therapy plus Biotin capsules (5 mg twice daily) for 3 months.

Drug: Biotin Capsules

Interventions

Placebo DRUG

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

Placebo

L-Carnitine 500Mg Oral Tablet DRUG

Group 2 (n=22) which will receive traditional therapy plus L-carnitine capsules (500 mg twice daily) for 3 months.

L-carnitine

Biotin Capsules DRUG

Group 3 (n=22) which will receive traditional therapy plus Biotin capsules (5 mg twice daily) for 3 months.

Biotin

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children with moderate persistent asthma
• Age range of 8-\< 18 years old
• Both sex

You may not qualify if:

• 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.
• Children with recent infection (especially pneumonia), surgery, anesthesia.
• Children having clinical evidence of any heart renal and hepatic diseases.
• Children having cystic fibrosis or congenital respiratory disease.
• Children having chronic diarrhea and mal-absorption.
• Children having clinical evidence of malnutrition.
• Children on medications that could interfere with L-carnitine level including antibiotics use. (particularly ampicillins) and anti- convulsing particularly valoproic acid.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospital

Tanta, Gharbia Governorate, 6620010, Egypt

Location

MeSH Terms

Interventions

Carnitine; Tablets; Biotin

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical pharmacist

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 30, 2022
• Study Start: August 8, 2022
• Primary Completion: August 8, 2024
• Study Completion: August 8, 2024
• Last Updated: November 30, 2022

Record last verified: 2022-11

Locations

EG (1)