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Trial registered on ANZCTR
Registration number
ACTRN12614000863639
Ethics application status
Approved
Date submitted
4/08/2014
Date registered
12/08/2014
Date last updated
25/07/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
Effect of sunlight exposure on vitamin D status: A pilot randomized controlled trial
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Scientific title
To what extent does natural sun exposure three times a week for three weeks affect vitamin D levels in fair-skinned indoor workers compared to those not receiving any extra sun exposure than the amount they receive in their day to day activity?
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Secondary ID [1]
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Nil
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Universal Trial Number (UTN)
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Trial acronym
D-UV
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
vitamin D insufficiency/deficiency
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Condition category
Condition code
Public Health
291734
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0
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Epidemiology
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Exposure to 1 standard erythemal dose (SED) UV radiation from natural sunlight three times per week for three weeks. 1 SED, which is half the amount of UV radiation required to produce sunburn and takes about 9-12 minutes to achieve in Brisbane in the month of August and September [Samanek et al., 2006].
The dose will be monitored using a portable UV detector, which alarms when a set exposure is received.
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Intervention code [1]
289771
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Lifestyle
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Comparator / control treatment
No sun exposure
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Control group
Active
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Outcomes
Primary outcome [1]
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25-hydroxyvitamin D concentration (25(OH)D).
Serum 25(OH)D in blood samples will me assessed using a Diasorin Liaison assay.
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Assessment method [1]
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Timepoint [1]
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Baseline, 1,2,3 and 7 weeks after intervention commences
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Secondary outcome [1]
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Total UV received.
The on and off trial UV received by participants will be measured using polysulphone dosimeters. Each participant will wear a dosimeter each day for three weeks during the trial (21 in total).
Participants will insert the dosimeter into a silicone wristband and wear it on their left wrist from the time they arise in the morning until they retire at night, taking care to ensure that the dosimeter is not obstructed by clothing or jewelry. They will be asked to place the dosimeter back in its packet at the end of the day to avoid possible saturation of the dosimeter’s capacity to register UV exposure.
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Assessment method [1]
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Timepoint [1]
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Once every day for three weeks.
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Eligibility
Key inclusion criteria
1. Adults aged 18-60 yrs
2. Fair-skinned (Fitzpatrick skin type II-III)
3. Indoor workers (at least 80% FTE)
4. Residing in Brisbane for the duration of the study
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Minimum age
18
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Spending more than 15 mins/day in the sun between 8 am and 4 pm
2. History of excision of keratinocytic lesions (in the last 5 years)
3. Any past history of melanoma
4. Skin photosensitivity disorder
5. Bleeding disorder (for example, haemophilia)
6. Taking vitamin D supplements and unwilling to stop taking them
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
6/08/2014
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Actual
6/08/2014
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Date of last participant enrolment
Anticipated
12/09/2014
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Actual
17/09/2014
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Date of last data collection
Anticipated
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Actual
7/11/2014
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Sample size
Target
100
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Accrual to date
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Final
36
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Recruitment in Australia
Recruitment state(s)
QLD
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Queensland University of Technology,
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Address [1]
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Cnr Musk and Victoria Park Rd
Kelvin Grove QLD 4059
GPO Box 2434
Brisbane, QLD 4001
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Queensland University of Technology
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Address
Cnr Musk and Victoria Park Rd
Kelvin Grove QLD 4059
GPO Box 2434
Brisbane, QLD 4001
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Country
Australia
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Secondary sponsor category [1]
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Other
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Name [1]
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CRE in Sun and Health
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Address [1]
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AusSun Research Lab
Institute of Health and Biomedical Innovation
60 Musk Avenue
Kelvin Grove Urban Village
Kelvin Grove, QLD 4059
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Country [1]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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HREC, Queensland University of Technology
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Ethics committee address [1]
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Office of Research Ethics & Integrity Queensland University of Technology Level 4, 88 Musk Avenue, Kelvin Grove Campus Kelvin Grove QLD 4059 GPO Box 2434, BRISBANE QLD 4001
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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19/02/2014
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Approval date [1]
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13/06/2014
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Ethics approval number [1]
290946
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Summary
Brief summary
Vitamin D is essential for human well-being. Skin conversion of 7-dehydrocholesterol to previtamin D3 by UVB radiation from sun exposure remain the most abundant source of vitamin D for most humans. Available evidence suggests that relatively high proportions of people in many different countries, including in Australia and New Zealand, have low vitamin D status. However exposure to the sun causes skin cancer and it is therefore critical to develop a better understanding about possible balance between the risks and benefits of sun exposure. In particular, it is important to know how much sun exposure is needed to optimize vitamin D in different groups of people. The aim of the study is to measure the magnitude of effect of natural sun exposure three days a week for three weeks on the vitamin D level of fair-skinned indoor workers. This study will be a two-arm randomized controlled trial. Fair-skinned indoor workers aged 18 to 60 years will be randomized into two groups – control and intervention. Participants in the intervention group will be exposed to natural sunlight three days a week for three weeks while those in the control group will go about their business as usual. Blood samples will be collected from the participants pre- and post-intervention to study their levels of vitamin D. A follow up blood sample will be collected from all participants four weeks after the intervention to determine any wash-out effect. The participants’ incidental sun exposure will be monitored through UV monitors. Questionnaires will be administered to gather demographic, sun exposure and sun protection behavior as well as outdoor activity in the weekends during the intervention period. It is anticipated that this study will offer us a better understanding about the extent of effect sunlight has on vitamin D levels of people with fair skin.
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Trial website
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Trial related presentations / publications
Khan, S. R., Whiteman, D. C., Kimlin, M. G., Janda, M., Clarke, M., Lucas, R., and Neale R. E. (2018), The effect of intentional sun exposure on 25(OH)D concentration in indoor workers: evidence from a randomized controlled trial. Presented at the NIWA UV Workshop, Wellington, New Zealand. 4-6 April 2018. Khan, S. R., Whiteman, D. C., Kimlin, M. G., Janda, M., Clarke, M., Lucas, R., and Neale R. E. (2018), Effect of solar ultraviolet radiation exposure on serum 25(OH)D concentration: A pilot randomized controlled trial. Photochemical & Photobiological Sciences, 17: 570-577.
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Public notes
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Contacts
Principal investigator
Name
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Ms Shanchita Khan
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Address
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Institute of Health and Biomedical Innovation
Queensland University of Technology, 60 Musk Ave, Kelvin Grove, QLD 4059, Australia
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Country
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Australia
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Phone
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+61731380401
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Michael Kimlin
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Address
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Institute of Health and Biomedical Innovation
Queensland University of Technology, 60 Musk Ave, Kelvin Grove, QLD 4059, Australia
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Country
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Australia
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Phone
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+61731385802
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Fax
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+61731386030
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Email
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[email protected]
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Contact person for scientific queries
Name
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Shanchita Khan
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Address
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Institute of Health and Biomedical Innovation
Queensland University of Technology, 60 Musk Ave, Kelvin Grove, QLD 4059, Australia
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Country
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Australia
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Phone
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+61731380401
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Fax
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Email
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[email protected]
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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.
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