Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000149561
Ethics application status
Approved
Date submitted
23/04/2006
Date registered
1/05/2006
Date last updated
1/05/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Zinc supplementation in asthma
Scientific title
The effect of oral Zinc supplementation in asthma in reducing the dose of inhaled steroids
Secondary ID [1] 256 0
The Queen Elizabeth Hospital Ethics Committee: 2006014
Universal Trial Number (UTN)
Trial acronym
OZSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 1121 0
Condition category
Condition code
Respiratory 1199 1199 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral Zinc
50 mg Zn daily for 4 months
Intervention code [1] 992 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 1627 0
Reduction in inhaled steroid dose
Timepoint [1] 1627 0
At 4 months
Secondary outcome [1] 2915 0
Peak expiratory flow variability
Timepoint [1] 2915 0
Secondary outcome [2] 2916 0
Postbronchodilator forced expired volume in 1 second
Timepoint [2] 2916 0
Secondary outcome [3] 2917 0
Exhaled nitric oxide concentration
Timepoint [3] 2917 0
Secondary outcome [4] 2918 0
Quality of life
Timepoint [4] 2918 0

Eligibility
Key inclusion criteria
Persistent asthma: on 400ug of budesonide or equivalent toachieve good to moderate asthma control.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prednisolone or exacerbation within 3 months :smoking in last 2 years.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
third person allocation schedule "off-site"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number by computer program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1312 0
University
Name [1] 1312 0
Department of Medicine, Adelaide University funds
Country [1] 1312 0
Australia
Primary sponsor type
University
Name
Adelaide University
Address
Country
Australia
Secondary sponsor category [1] 1159 0
None
Name [1] 1159 0
Nil at this time
Address [1] 1159 0
Country [1] 1159 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2641 0
The Queen Elizaeth Hospital & Lyell McEwin Hspital branch of the Central Nortern AdelaideHealth Service Ethics of Human Research Committee
Ethics committee address [1] 2641 0
Ethics committee country [1] 2641 0
Australia
Date submitted for ethics approval [1] 2641 0
Approval date [1] 2641 0
Ethics approval number [1] 2641 0
2006014

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36263 0
Address 36263 0
Country 36263 0
Phone 36263 0
Fax 36263 0
Email 36263 0
Contact person for public queries
Name 10181 0
Executive Officer (Currently Ms K Hoffman)
Address 10181 0
Research Secretariat
The Queen Elizabeth Hospital
28 Woodville Rd
Woodville SA 5011
Country 10181 0
Australia
Phone 10181 0
+61 8 82226841
Fax 10181 0
Email 10181 0
kelly.hoffman@nwahs.sa.gov.au
Contact person for scientific queries
Name 1109 0
Professor Richard Ruffin
Address 1109 0
Department of Medicine
The Queen Elizabeth Hospital Campus
Adelaide University
The Queen Elizabeth Hospital
Ward 5B
28 Woodville Rd
Woodville SA 5011
Country 1109 0
Australia
Phone 1109 0
+61 8 82226740
Fax 1109 0
+61 8 82226042
Email 1109 0
richard.ruffin@adelaide.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.