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

Tanta University

Status and phase: Active, not recruiting; Phase 3

Conditions: Moderate Persistent Asthma

Treatments: Drug: Biotin Capsules; Drug: L-Carnitine 500Mg Oral Tablet; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05632549

35652/8/22

Details and patient eligibility

About

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

Enrollment: 66 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Group 1 (n=22) which will receive traditional therapy plus placebo capsule twice daily for 3 months.

Treatment:

Drug: Placebo

L-carnitine

Experimental group

Description:

Group 2 (n=22) which will receive traditional therapy plus L-carnitine capsules (500 mg twice daily) for 3 months.

Treatment:

Drug: L-Carnitine 500Mg Oral Tablet

Biotin

Experimental group

Description:

Group 3 (n=22) which will receive traditional therapy plus Biotin capsules (5 mg twice daily) for 3 months.

Treatment:

Drug: Biotin Capsules