Back to resultsThe Possible Efficacy and Safety of L-carnitine and Biotin as Adjunctive Therapies in Children With Moderate Persistent Asthma
Primary Purpose
Moderate Persistent Asthma
Status
Active
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Placebo
L-Carnitine 500Mg Oral Tablet
Biotin Capsules
Sponsored by
About this trial
This is an interventional treatment trial for Moderate Persistent Asthma
Eligibility Criteria
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.
Sites / Locations
- Tanta University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
L-carnitine
Biotin
Arm Description
Group 1 (n=22) which will receive traditional therapy plus placebo capsule twice daily for 3 months.
Group 2 (n=22) which will receive traditional therapy plus L-carnitine capsules (500 mg twice daily) for 3 months.
Group 3 (n=22) which will receive traditional therapy plus Biotin capsules (5 mg twice daily) for 3 months.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
serum levels of TGF-β1
the change in serum levels of TGF-β1
serum levels of TNF-α
Change in serum level of TNF-α
serum levels of 8-OHDG
the change in serum levels of 8-OHDG
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05632549
Brief Title
The Possible Efficacy and Safety of L-carnitine and Biotin as Adjunctive Therapies in Children With Moderate Persistent Asthma
Official Title
The Possible Efficacy and Safety of L-carnitine and Biotin as Adjunctive Therapies in Children With Moderate Persistent Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 8, 2022 (Actual)
Primary Completion Date
August 8, 2024 (Anticipated)
Study Completion Date
August 8, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The Possible Efficacy and Safety of L-carnitine and Biotin as Adjunctive Therapies in Children with Moderate Persistent Asthma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate Persistent Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Group 1 (n=22) which will receive traditional therapy plus placebo capsule twice daily for 3 months.
Arm Title
L-carnitine
Arm Type
Experimental
Arm Description
Group 2 (n=22) which will receive traditional therapy plus L-carnitine capsules (500 mg twice daily) for 3 months.
Arm Title
Biotin
Arm Type
Experimental
Arm Description
Group 3 (n=22) which will receive traditional therapy plus Biotin capsules (5 mg twice daily) for 3 months.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Group 1 (n=22) which will receive traditional therapy plus placebo capsule twice daily for 3 months.
Intervention Type
Drug
Intervention Name(s)
L-Carnitine 500Mg Oral Tablet
Intervention Description
Group 2 (n=22) which will receive traditional therapy plus L-carnitine capsules (500 mg twice daily) for 3 months.
Intervention Type
Drug
Intervention Name(s)
Biotin Capsules
Intervention Description
Group 3 (n=22) which will receive traditional therapy plus Biotin capsules (5 mg twice daily) for 3 months.
Primary Outcome Measure Information:
Title
Pulmonary function test (PFT)
Description
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.
Time Frame
3 months
Title
Childhood asthma control test (C-ACT)
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
serum levels of TGF-β1
Description
the change in serum levels of TGF-β1
Time Frame
at baseline and 3 months after intervention
Title
serum levels of TNF-α
Description
Change in serum level of TNF-α
Time Frame
at baseline and 3 months after intervention
Title
serum levels of 8-OHDG
Description
the change in serum levels of 8-OHDG
Time Frame
at baseline and 3 months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Tanta University Hospital
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
6620010
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
The Possible Efficacy and Safety of L-carnitine and Biotin as Adjunctive Therapies in Children With Moderate Persistent Asthma
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