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

NCT06869798 | Completed Phase 3 DMC

• 1 other identifier: 4141/REG/KEMU/22MD200024
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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. 1.Improvement in asthma control as measured by the Asthma Control Test (ACT) score.
2. 2.Association of continuous variables (e.g., age and duration of illness) and categorical variables (e.g., sex) with asthma control.

Conditions

Asthma in Children

Keywords

asthma in children; zinc; standard therapy; adjuvant

Outcome Measures

Primary Outcomes (2)

• Change in Asthma Control Test (ACT) Scores From Baseline to 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

  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

Study Arms (2)

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

EXPERIMENTAL

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

n Group B will receive only Standard therapy.

EXPERIMENTAL

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

Interventions

zinc sulphate 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 A will receive standard therapy along with oral zinc 20mg/day OD for 2 months; n Group B will receive only Standard therapy.

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

King Edward Medical University Lahore Pakistan

Lahore, Punjab Province, 05499, Pakistan

Location

Related Publications (6)

• 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.

  PMID: 29316003 BACKGROUND

• 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.

  PMID: 29115880 BACKGROUND

• 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.

  PMID: 33274952 BACKGROUND

• 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.

  PMID: 28058103 BACKGROUND

• 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.

  PMID: 23312452 BACKGROUND

• 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.

  PMID: 31685060 BACKGROUND

MeSH Terms

Interventions

Zinc Sulfate

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds

Study Officials

• Sadia Shabbir, MBBS,FCPS

  Pediatrics Department King Edward Medical University Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD (Postgraduate Trainee)

Model Details: Randamize clinical trial

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: March 11, 2025
• Study Start: September 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: August 28, 2023
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)