Clinical trial NCT06869798: EFFECTIVENESS of ZINC AS an ADJUVANT to STANDARD THERAPY VERSUS STANDARD THERAPY ALONE in CHILDREN
Official title: EFFECTIVENESS of ZINC AS an ADJUVANT to STANDARD THERAPY VERSUS STANDARD THERAPY ALONE in CHILDREN (5-10 YEARS) with MODERATE PERSISTENT ASTHMA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma in Children
Keywords: asthma in children
zinc
standard therapy
adjuvant
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 84
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randamize clinical trial
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change in Asthma Control Test (ACT) Scores From Baseline to 8 Weeks
timeFrame: Baseline, 4 weeks and 8 Weeks
measure: Number of Emergency Visits Due to Asthma Exacerbation
timeFrame: Baseline, 4 weeks and 8 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: King Edward Medical University Lahore Pakistan
state: Punjab
Study officials:
affiliation: Pediatrics Department King Edward Medical University Lahore
name: Sadia Shabbir, MBBS,FCPS
role: PRINCIPAL_INVESTIGATOR
References:
citation: King GG, James A, Harkness L, Wark PAB. Pathophysiology of severe asthma: We've only just started. Respirology. 2018 Mar;23(3):262-271. doi: 10.1111/resp.13251. Epub 2018 Jan 9.
citation: Vijverberg SJH, Farzan N, Slob EMA, Neerincx AH, Maitland-van der Zee AH. Treatment response heterogeneity in asthma: the role of genetic variation. Expert Rev Respir Med. 2018 Jan;12(1):55-65. doi: 10.1080/17476348.2018.1403318. Epub 2017 Nov 21.
citation: Siripornpanich S, Chongviriyaphan N, Manuyakorn W, Matangkasombut P. Zinc and vitamin C deficiencies associate with poor pulmonary function in children with persistent asthma. Asian Pac J Allergy Immunol. 2022 Jun;40(2):103-110. doi: 10.12932/AP-100620-0878.
citation: Rerksuppaphol S, Rerksuppaphol L. Zinc Supplementation in Children with Asthma Exacerbation. Pediatr Rep. 2016 Dec 9;8(4):6685. doi: 10.4081/pr.2016.6685. eCollection 2016 Nov 17.
citation: Khanbabaee G, Omidian A, Imanzadeh F, Adibeshgh F, Ashayeripanah M, Rezaei N. Serum level of zinc in asthmatic patients: a case-control study. Allergol Immunopathol (Madr). 2014 Jan-Feb;42(1):19-21. doi: 10.1016/j.aller.2012.07.008. Epub 2013 Jan 9.
citation: Chen M, Sun Y, Wu Y. Lower circulating zinc and selenium levels are associated with an increased risk of asthma: evidence from a meta-analysis. Public Health Nutr. 2020 Jun;23(9):1555-1562. doi: 10.1017/S1368980019003021. Epub 2019 Nov 5.