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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Moderate Persistent Asthma
• Intervention / Treatment: Drug: Placebo; Drug: L-Carnitine 500Mg Oral Tablet; Drug: Biotin Capsules

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Gharbia
    • Tanta, Gharbia, Egypt, 6620010
      • Tanta university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Group 1 (n=22) which will receive traditional therapy plus placebo capsule twice daily for 3 months.	Drug: Placebo; Group 1 (n=22) which will receive traditional therapy plus placebo capsule twice daily for 3 months.
Experimental: L-carnitine; 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; Group 2 (n=22) which will receive traditional therapy plus L-carnitine capsules (500 mg twice daily) for 3 months.
Experimental: Biotin; Group 3 (n=22) which will receive traditional therapy plus Biotin capsules (5 mg twice daily) for 3 months.	Drug: Biotin Capsules; Group 3 (n=22) which will receive traditional therapy plus Biotin capsules (5 mg twice daily) for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum levels of TGF-β1	the change in serum levels of TGF-β1	at baseline and 3 months after intervention
serum levels of TNF-α	Change in serum level of TNF-α	at baseline and 3 months after intervention
serum levels of 8-OHDG	the change in serum levels of 8-OHDG	at baseline and 3 months after intervention

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2022
• Primary Completion (Anticipated): August 8, 2024
• Study Completion (Anticipated): August 8, 2024

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 29, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Biotin
• Other Study ID Numbers: 35652/8/22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No