Trial Review

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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
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?
Secondary ID [1] 284251 0
Nil
Universal Trial Number (UTN)
Trial acronym
D-UV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
vitamin D insufficiency/deficiency 291368 0
Condition category
Condition code
Public Health 291734 291734 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 289771 0
Lifestyle
Comparator / control treatment
No sun exposure
Control group
Active

Outcomes
Primary outcome [1] 292597 0
25-hydroxyvitamin D concentration (25(OH)D).
Serum 25(OH)D in blood samples will me assessed using a Diasorin Liaison assay.
Timepoint [1] 292597 0
Baseline, 1,2,3 and 7 weeks after intervention commences
Secondary outcome [1] 309304 0
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.
Timepoint [1] 309304 0
Once every day for three weeks.

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
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/08/2014
Actual
6/08/2014
Date of last participant enrolment
Anticipated
12/09/2014
Actual
17/09/2014
Date of last data collection
Anticipated
Actual
7/11/2014
Sample size
Target
100
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 289170 0
University
Name [1] 289170 0
Queensland University of Technology,
Country [1] 289170 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Cnr Musk and Victoria Park Rd
Kelvin Grove QLD 4059

GPO Box 2434
Brisbane, QLD 4001
Country
Australia
Secondary sponsor category [1] 287839 0
Other
Name [1] 287839 0
CRE in Sun and Health
Address [1] 287839 0
AusSun Research Lab
Institute of Health and Biomedical Innovation
60 Musk Avenue
Kelvin Grove Urban Village
Kelvin Grove, QLD 4059
Country [1] 287839 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290946 0
HREC, Queensland University of Technology
Ethics committee address [1] 290946 0
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
Ethics committee country [1] 290946 0
Australia
Date submitted for ethics approval [1] 290946 0
19/02/2014
Approval date [1] 290946 0
13/06/2014
Ethics approval number [1] 290946 0

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.
Trial website
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.
Public notes

Contacts
Principal investigator
Name 46890 0
Ms Shanchita Khan
Address 46890 0
Institute of Health and Biomedical Innovation
Queensland University of Technology, 60 Musk Ave, Kelvin Grove, QLD 4059, Australia
Country 46890 0
Australia
Phone 46890 0
+61731380401
Fax 46890 0
Email 46890 0
[email protected]
Contact person for public queries
Name 46891 0
Prof Michael Kimlin
Address 46891 0
Institute of Health and Biomedical Innovation
Queensland University of Technology, 60 Musk Ave, Kelvin Grove, QLD 4059, Australia
Country 46891 0
Australia
Phone 46891 0
+61731385802
Fax 46891 0
+61731386030
Email 46891 0
[email protected]
Contact person for scientific queries
Name 46892 0
Ms Shanchita Khan
Address 46892 0
Institute of Health and Biomedical Innovation
Queensland University of Technology, 60 Musk Ave, Kelvin Grove, QLD 4059, Australia
Country 46892 0
Australia
Phone 46892 0
+61731380401
Fax 46892 0
Email 46892 0
[email protected]

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

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