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

Study Overview
=================
Brief Summary
-----------------
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

Conditions
-----------------
Moderate Persistent Asthma

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: L-Carnitine 500Mg Oral Tablet
* Drug: Biotin Capsules


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

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 |