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
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
Trial website
Trial related presentations / publications
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
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
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

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

Documents added automatically
No additional documents have been identified.