The Possible Efficacy and Safety of L-carnitine and Biotin as Adjunctive Therapies in Children with Moderate Persistent Asthma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
66
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.
Tanta University Hospital
Tanta, Gharbia Governorate, Egypt
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.
Time frame: 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.
Time frame: 3 months
serum levels of TGF-β1
the change in serum levels of TGF-β1
Time frame: at baseline and 3 months after intervention
serum levels of TNF-α
Change in serum level of TNF-α
Time frame: at baseline and 3 months after intervention
serum levels of 8-OHDG
the change in serum levels of 8-OHDG
Time frame: at baseline and 3 months after intervention
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