Moderate Persistent AsthmaPhase 3NCT05632549
The Possible Efficacy and Safety of L-carnitine and Biotin as Adjunctive Therapies in Children With Moderate Persistent Asthma
A Phase 3 study testing L-Carnitine 500Mg Oral Tablet and Biotin Capsules in people with Moderate Persistent Asthma, run by Tanta University at 1 site in Egypt.
Trial summary
The Possible Efficacy and Safety of L-carnitine and Biotin as Adjunctive Therapies in Children with Moderate Persistent Asthma Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Moderate Persistent Asthma
- What is being tested?
- L-Carnitine 500Mg Oral Tablet and Biotin Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Aug 2022to 8 Aug 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children with moderate persistent asthma
- Age range of 8-< 18 years old
- Both sex
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The Possible Efficacy and Safety of L-carnitine and Biotin as Adjunctive Therapies in Children with Moderate Persistent Asthma
- Conditions
- Moderate Persistent Asthma
- Being tested
- Placebo, L-Carnitine 500Mg Oral Tablet, Biotin Capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Group 1 (n=22) which will receive traditional therapy plus placebo capsule twice daily for 3 months.
L-Carnitine 500Mg Oral TabletDrug
Group 2 (n=22) which will receive traditional therapy plus L-carnitine capsules (500 mg twice daily) for 3 months.
Biotin CapsulesDrug
Group 3 (n=22) which will receive traditional therapy plus Biotin capsules (5 mg twice daily) for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Group 1 (n=22) which will receive traditional therapy plus placebo capsule twice daily for 3 months. Receives: Drug: Placebo |
| L-carnitine | Experimental | Group 2 (n=22) which will receive traditional therapy plus L-carnitine capsules (500 mg twice daily) for 3 months. Receives: Drug: L-Carnitine 500Mg Oral Tablet |
| Biotin | Experimental | Group 3 (n=22) which will receive traditional therapy plus Biotin capsules (5 mg twice daily) for 3 months. Receives: Drug: Biotin Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months
Secondary outcomes (3)
serum levels of TGF-β1
the change in serum levels of TGF-β1
Measured: at baseline and 3 months after intervention
serum levels of TNF-α
Change in serum level of TNF-α
Measured: at baseline and 3 months after intervention
serum levels of 8-OHDG
the change in serum levels of 8-OHDG
Measured: at baseline and 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start8 Aug 2022
- Primary completion8 Aug 2024 (estimated)
- Study completion8 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate Persistent AsthmaStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed osama khedr, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632549
- Sponsor's protocol ID
- 35652/8/22
- Status last verified
- Nov 2022
- First submitted
- 10 Nov 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Possible Efficacy and Safety of L-carnitine and Biotin as Adjunctive Therapies in Children With Moderate Persistent Asthma
- ClinicalTrials.gov ID
- NCT05632549
- Acronym / sponsor ID
- 35652/8/22
- Conditions
- Moderate Persistent Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 8 Aug 2024 (estimated)
- Study completion
- 8 Aug 2024 (estimated)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Possible Efficacy and Safety of L-carnitine and Biotin as Adjunctive Therapies in Children with Moderate Persistent Asthma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboGroup 1 (n=22) which will receive traditional therapy plus placebo capsule twice daily for 3 months. |
| L-carnitine | Experimental | Drug: L-Carnitine 500Mg Oral TabletGroup 2 (n=22) which will receive traditional therapy plus L-carnitine capsules (500 mg twice daily) for 3 months. |
| Biotin | Experimental | Drug: Biotin CapsulesGroup 3 (n=22) which will receive traditional therapy plus Biotin capsules (5 mg twice daily) for 3 months. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children with moderate persistent asthma
- Age range of 8-< 18 years old
- Both sex
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboGroup 1 (n=22) which will receive traditional therapy plus placebo capsule twice daily for 3 months. | Drug | Placebo |
| L-Carnitine 500Mg Oral TabletGroup 2 (n=22) which will receive traditional therapy plus L-carnitine capsules (500 mg twice daily) for 3 months. | Drug | L-carnitine |
| Biotin CapsulesGroup 3 (n=22) which will receive traditional therapy plus Biotin capsules (5 mg twice daily) for 3 months. | Drug | Biotin |
Primary outcome
Pulmonary function test (PFT)
Time frame: 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)
Time frame: 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.
3 secondary outcomes
serum levels of TGF-β1
Time frame: at baseline and 3 months after intervention
serum levels of TNF-α
Time frame: at baseline and 3 months after intervention
serum levels of 8-OHDG
Time frame: at baseline and 3 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing L-Carnitine 500Mg Oral Tablet and Biotin Capsules in people with Moderate Persistent Asthma, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function test (PFT) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.