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

Moderate Persistent Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05632549
• Other study ID #: 35652/8/22
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 8, 2022
• Est. completion date: August 8, 2024

Study information

• Verified date: November 2022
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 66
• Est. completion date: August 8, 2024
• Est. primary completion date: August 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Moderate Persistent Asthma

Intervention

Drug:
• Placebo
Group 1 (n=22) which will receive traditional therapy plus placebo capsule twice daily for 3 months.
• 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.
• Biotin Capsules
Group 3 (n=22) which will receive traditional therapy plus Biotin capsules (5 mg twice daily) for 3 months.

Locations

Country	Name	City	State
Egypt	Tanta University Hospital	Tanta	Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	serum levels of TGF-ß1	the change in serum levels of TGF-ß1	at baseline and 3 months after intervention
Secondary	serum levels of TNF-a	Change in serum level of TNF-a	at baseline and 3 months after intervention
Secondary	serum levels of 8-OHDG	the change in serum levels of 8-OHDG	at baseline and 3 months after intervention