EFFECTIVENESS of ZINC AS an ADJUVANT to STANDARD THERAPY VERSUS STANDARD THERAPY ALONE in CHILDREN

Phase 3

Completed

• Conditions: Asthma in Children
• Interventions: Drug: zinc sulphate

• Registration Number: NCT06869798
• Lead Sponsor: King Edward Medical University

Brief Summary

The objective of this study is to compare the effectiveness of zinc as an adjuvant to standard therapy versus standard therapy alone in children with moderate persistent asthma, as assessed by the Asthma Control Test, in terms of:

1. Improvement in asthma control as measured by the Asthma Control Test (ACT) score.

2. Association of continuous variables (e.g., age and duration of illness) and categorical variables (e.g., sex) with asthma control.

HYPOTHESIS Zinc as an adjuvant to standard therapy is more effective than standard therapy alone in managing moderate persistent asthma in children.

Detailed Description

DESIGN OF STUDY This is a Randomized Controlled Trial. FOLLOW-UP PROTOCOL The patients will be evaluated at the beginning of the study and then followed up at four weeks and eight weeks after enrollment to assess the primary and secondary outcomes. PRIMARY OUTCOME To assess the improvement in asthma control based on the Asthma Control Test (ACT) score at 4 weeks and 8 weeks, respectively. SECONDARY OUTCOMES

To observe improvement in:

1. Asthma symptoms and medication use, as recorded in patient diaries.

2. Association of continuous variables (e.g., age, duration of illness) and categorical variables (e.g., sex) with asthma control. SAMPLE SIZE The Calculated sample size is 84 children (42 in each group: Intervention \& Control arm). SAMPLING TECHNIQUE Simple random sampling using the lottery method. SAMPLE SELECTION INCLUSION CRITERIA

1. Children ( 5-10) years. 2. Either gender. 3.Patient diagnosed with asthma according to the operational definition 4.Child with acute exacerbation of asthma EXCLUSION CRITERIA

1. Children with diarrhea and malnutrition

2. Children with pulmonary disease(pneumonia, viral infection,cystic fibrosis)

3. Children with cardiovascular disease. . 4. Children already taking zinc supplementation. STUDY PROCEDURE After approval from the Institutional Review Board of King Edward Medical University, Mayo Hospital, Lahore, all children aged 5 to 10 years, of either gender, diagnosed with asthma as per the operational definition and fulfilling the inclusion criteria, presenting to the Department of Pediatric Medicine, Mayo Hospital, will be enrolled in this study. Verbal and informed written consent will be obtained from the parents/guardians of all participants. Data Collection \& Randomization

1. Demographic data will be collected. 2. A detailed history regarding symptoms, onset, duration of illness, progression, medication, level of asthma control, and general physical and systemic examination will be conducted. 3. Patients with moderate persistent asthma will be identified. 4. Using simple random sampling (lottery method), patients will be assigned into two groups:

1. Group A (Intervention): Standard therapy + Oral Zinc 20mg/day OD for 2 months.

2. Group B (Control): Standard therapy only. Follow-Up \& Assessment All patients will be trained to maintain a diary, documenting responses to the

1. Asthma Control Test (ACT) and medication use.

2. Patients will be followed up every 4 weeks for 8 weeks to evaluate asthma control and symptom improvement.

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2022-06-22
• Primary Completion: 2022-10-01
• Study Completion: 2023-08-28
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-05
• Last Update Submitted: 2025-03-21
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
n Group A will receive standard therapy along with oral zinc 20mg/day OD for 2 months	zinc sulphate	n Group A will receive standard therapy along with oral zinc 20mg/day OD for 2 months., all the patients of both groups will be trained to maintain diary regarding questionnaire asked in asthma control test, followed up 4 weekly for 8 weeks
n Group B will receive only Standard therapy.	zinc sulphate	n Group B will receive only Standard therapy., all the patients of both groups will be trained to maintain diary regarding questionnaire asked in asthma control test, followed up 4 weekly for 8 weeks

Primary Outcome Measures

Name	Time	Method
Change in Asthma Control Test (ACT) Scores From Baseline to 8 Weeks	Baseline, 4 weeks and 8 Weeks	The effectiveness of zinc as an adjuvant to standard therapy in children with moderate persistent asthma will be assessed by changes in Asthma Control Test (ACT) scores.; Scores will be categorized as: * Controlled- if ACT score ≥ 20; * Partially Controlled- if ACT score is 16-19; * Uncontrolled- if ACT score \< 16; The intervention will be considered effective if there is a statistically significant increase in ACT scores from baseline to 8 weeks.
Number of Emergency Visits Due to Asthma Exacerbation	Baseline, 4 weeks and 8 Weeks	The total number of emergency visits due to asthma exacerbation will be recorded at each follow-up. A reduction in emergency visits will be considered indicative of effective treatment.

Trial Locations

Locations (1)

King Edward Medical University Lahore Pakistan; 🇵🇰 Lahore, Punjab, Pakistan