Moderate Persistent Asthma
Conditions
Brief summary
The Possible Efficacy and Safety of L-carnitine and Biotin as Adjunctive Therapies in Children with Moderate Persistent Asthma
Interventions
DRUGPlacebo
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.
DRUGBiotin Capsules
Group 3 (n=22) which will receive traditional therapy plus Biotin capsules (5 mg twice daily) for 3 months.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| serum levels of 8-OHDG | at baseline and 3 months after intervention | the change in serum levels of 8-OHDG |
Countries
Egypt
Outcome results
None listed