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

King Edward Medical University

Status and phase: Completed; Phase 3

Conditions: Asthma in Children

Treatments: Drug: zinc sulphate

Study type: Interventional

Funder types: Other

Identifiers

NCT06869798

4141/REG/KEMU/22MD200024

Details and patient eligibility

About

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.

Full 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

3. 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

4. Children with diarrhea and malnutrition

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

6. 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

7. 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:

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

9. 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.

Enrollment: 84 patients

Sex: All

Ages: 5 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Children ( 5-10) years.
• Either gender.
• Patient diagnosed with asthma according to the operational definition
• Child with acute exacerbation of asthma

Exclusion criteria

• Children with diarrhea and malnutrition
• Children with pulmonary disease(pneumonia, viral infection,cystic fibrosis)
• Children with cardiovascular disease. . • Children already taking zinc supplementation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups

n Group A will receive standard therapy along with oral zinc 20mg/day OD for 2 months

Experimental group

Description:

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

Treatment:

Drug: zinc sulphate

n Group B will receive only Standard therapy.

Experimental group

Description:

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

Treatment:

Drug: zinc sulphate