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

Phase 3

Active, not recruiting

• Conditions: Moderate Persistent Asthma
• Interventions: Drug: Biotin Capsules; Drug: Placebo; Drug: L-Carnitine 500Mg Oral Tablet

• Registration Number: NCT05632549
• Lead Sponsor: Tanta University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-08
• Status Verified: 2022-11
• Study First Submitted: 2022-11-10
• Study First Submitted QC: 2022-11-29
• Last Update Submitted: 2022-11-29
• Study First Posted: 2022-11-30
• Last Update Posted: 2022-11-30
• Primary Completion: 2024-08-08
• Study Completion: 2024-08-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biotin	Biotin Capsules	Group 3 (n=22) which will receive traditional therapy plus Biotin capsules (5 mg twice daily) for 3 months.
Placebo	Placebo	Group 1 (n=22) which will receive traditional therapy plus placebo capsule twice daily for 3 months.
L-carnitine	L-Carnitine 500Mg Oral Tablet	Group 2 (n=22) which will receive traditional therapy plus L-carnitine capsules (500 mg twice daily) for 3 months.

Primary Outcome Measures

Name	Time	Method
Pulmonary function test (PFT)	3 months	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.
Childhood asthma control test (C-ACT)	3 months	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.

Secondary Outcome Measures

Name	Time	Method
serum levels of 8-OHDG	at baseline and 3 months after intervention	the change in serum levels of 8-OHDG
serum levels of TGF-β1	at baseline and 3 months after intervention	the change in serum levels of TGF-β1
serum levels of TNF-α	at baseline and 3 months after intervention	Change in serum level of TNF-α

Trial Locations

Locations (1)

Tanta University Hospital; 🇪🇬 Tanta, Gharbia, Egypt