Asthma in ChildrenPhase 3NCT06869798
EFFECTIVENESS OF ZINC AS AN ADJUVANT TO STANDARD THERAPY VERSUS STANDARD THERAPY ALONE IN CHILDREN
A Phase 3 study testing zinc sulphate in people with Asthma in Children, run by King Edward Medical University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- zinc sulphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2021to 28 Aug 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children ( 5-10) years.
- Either gender.
- Patient diagnosed with asthma according to the operational definition
- Child with acute exacerbation of asthma
Who cannot join
- Children with diarrhea and malnutrition
- Children with pulmonary disease(pneumonia, viral infection,cystic fibrosis)
- Children with cardiovascular disease. . • Children already taking zinc supplementation.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
King Edward Medical University Lahore Pakistan
Lahore, Punjab Province, 05499
About this study
Official title: 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:
- Improvement in asthma control as measured by the Asthma Control Test (ACT) score.
- 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.
Read the 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:
- Asthma symptoms and medication use, as recorded in patient diaries.
- 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
- 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
- Children with diarrhea and malnutrition
- Children with pulmonary disease(pneumonia, viral infection,cystic fibrosis)
- 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
- 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:
- Group A (Intervention): Standard therapy + Oral Zinc 20mg/day OD for 2 months.
- Group B (Control): Standard therapy only. Follow-Up \& Assessment All patients will be trained to maintain a diary, documenting responses to the
- Asthma Control Test (ACT) and medication use.
- Patients will be followed up every 4 weeks for 8 weeks to evaluate asthma control and symptom improvement.
- Conditions
- Asthma in Children
- Being tested
- zinc sulphate
- Keywords
- asthma in children, zinc, standard therapy, adjuvant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zinc sulphateDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: zinc sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 4 weeks and 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Sep 2021
- Primary completion1 Oct 2022
- Study completion28 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randamize clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaushal Shah, King Edward Medical University
- Investigators
- Sadia Shabbir, MBBS,FCPS, Principal investigator, Pediatrics Department King Edward Medical University Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869798
- Sponsor's protocol ID
- 4141/REG/KEMU/22MD200024
- Status last verified
- Mar 2025
- First submitted
- 22 Jun 2022
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the principal investigator, supervisor, and Institution Review Board will have access with patients data upon request
Publications
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.
PubMed 29316003Vijverberg 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.
PubMed 29115880Siripornpanich 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.
PubMed 33274952Rerksuppaphol 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.
PubMed 28058103Khanbabaee 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.
PubMed 23312452Chen 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.
PubMed 31685060
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVENESS OF ZINC AS AN ADJUVANT TO STANDARD THERAPY VERSUS STANDARD THERAPY ALONE IN CHILDREN (5-10 YEARS) WITH MODERATE PERSISTENT ASTHMA
- ClinicalTrials.gov ID
- NCT06869798
- Acronym / sponsor ID
- 4141/REG/KEMU/22MD200024
- Conditions
- Asthma in Children
- Keywords
- asthma in children, zinc, standard therapy, adjuvant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 28 Aug 2023 (actual)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Improvement in asthma control as measured by the Asthma Control Test (ACT) score.
- 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:
- Asthma symptoms and medication use, as recorded in patient diaries.
- 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
- 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
- Children with diarrhea and malnutrition
- Children with pulmonary disease(pneumonia, viral infection,cystic fibrosis)
- 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
- 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:
- Group A (Intervention): Standard therapy + Oral Zinc 20mg/day OD for 2 months.
- Group B (Control): Standard therapy only. Follow-Up \& Assessment All patients will be trained to maintain a diary, documenting responses to the
- Asthma Control Test (ACT) and medication use.
- Patients will be followed up every 4 weeks for 8 weeks to evaluate asthma control and symptom improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randamize clinical trial
| Arm | Type | Receives |
|---|---|---|
| n Group A will receive standard therapy along with oral zinc 20mg/day OD for 2 months | Experimental | Drug: zinc sulphaten 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 |
| n Group B will receive only Standard therapy. | Experimental | Drug: zinc sulphaten 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 |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children ( 5-10) years.
- Either gender.
- Patient diagnosed with asthma according to the operational definition
- Child with acute exacerbation of asthma
Key exclusion criteria (3 listed)
- Children with diarrhea and malnutrition
- Children with pulmonary disease(pneumonia, viral infection,cystic fibrosis)
- Children with cardiovascular disease. . • Children already taking zinc supplementation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zinc sulphateGroup 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 | Drug | 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. |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Results publication: PubMed 29316003King 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.
- Results publication: PubMed 29115880Vijverberg 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.
- Results publication: PubMed 33274952Siripornpanich 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.
- Results publication: PubMed 28058103Rerksuppaphol 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.
- Results publication: PubMed 23312452Khanbabaee 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.
- Results publication: PubMed 31685060Chen 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.
- Individual participant dataSharing planned: No. Only the principal investigator, supervisor, and Institution Review Board will have access with patients data upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sadia Shabbir, MBBS,FCPS principal investigator
Pediatrics Department King Edward Medical University Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing zinc sulphate in people with Asthma in Children, run by King Edward Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Asthma Control Test (ACT) Scores From Baseline to 8 Weeks (time frame: Baseline, 4 weeks and 8 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06869798, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.