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

March 21, 2025 updated by: Kaushal Shah, King Edward Medical University

EFFECTIVENESS of ZINC AS an ADJUVANT to STANDARD THERAPY VERSUS STANDARD THERAPY ALONE in CHILDREN (5-10 YEARS) with MODERATE PERSISTENT ASTHMA

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 05499
        • King Edward Medical University Lahore Pakistan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: n Group A will receive standard therapy along with oral zinc 20mg/day OD for 2 months
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
Drug: zinc sulphate

Group A (intervention) and Group B (non-intervention). The patients in Group A will receive standard therapy along with oral zinc 20mg/day OD for 2 months. While the patients in Group B will receive only Standard therapy.

Then, 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
Experimental: n Group B will receive only Standard therapy.
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
Drug: zinc sulphate

Group A (intervention) and Group B (non-intervention). The patients in Group A will receive standard therapy along with oral zinc 20mg/day OD for 2 months. While the patients in Group B will receive only Standard therapy.

Then, 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Asthma Control Test (ACT) Scores From Baseline to 8 Weeks
Time Frame: 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.
Baseline, 4 weeks and 8 Weeks
Number of Emergency Visits Due to Asthma Exacerbation
Time Frame: 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.
Baseline, 4 weeks and 8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Edward Medical University

Investigators

  • Principal Investigator: Sadia Shabbir, MBBS,FCPS, Pediatrics Department King Edward Medical University Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

August 28, 2023

Study Registration Dates

First Submitted

June 22, 2022

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 21, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4141/REG/KEMU/22MD200024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only the principal investigator, supervisor, and Institution Review Board will have access with patients data upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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