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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-08-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Asthma in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randamize clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Double Blind

Study Groups

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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

Group Type EXPERIMENTAL

zinc sulphate

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

zinc sulphate

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No