ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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

Condition category

Condition code

Public Health

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]

Lifestyle

Comparator / control treatment

No sun exposure

Control group

Active

Outcomes

Primary outcome [1]

25-hydroxyvitamin D concentration (25(OH)D).
Serum 25(OH)D in blood samples will me assessed using a Diasorin Liaison assay.

Timepoint [1]

Baseline, 1,2,3 and 7 weeks after intervention commences

Secondary outcome [1]

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]

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

Recruitment in Australia

Recruitment state(s)

QLD

Funding & Sponsors

Funding source category [1]

University

Name [1]

Queensland University of Technology,

Address [1]

Cnr Musk and Victoria Park Rd
Kelvin Grove QLD 4059

GPO Box 2434
Brisbane, QLD 4001

Country [1]

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]

Other

Name [1]

CRE in Sun and Health

Address [1]

AusSun Research Lab
Institute of Health and Biomedical Innovation
60 Musk Avenue
Kelvin Grove Urban Village
Kelvin Grove, QLD 4059

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

HREC, Queensland University of Technology

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

19/02/2014

Approval date [1]

13/06/2014

Ethics approval number [1]

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

Ms Shanchita Khan

Address

Institute of Health and Biomedical Innovation
Queensland University of Technology, 60 Musk Ave, Kelvin Grove, QLD 4059, Australia

Country

Australia

Phone

+61731380401

Fax

Shanchita.Khan@qimrberghofer.edu.au

Contact person for public queries

Name

Michael Kimlin

Address

Institute of Health and Biomedical Innovation
Queensland University of Technology, 60 Musk Ave, Kelvin Grove, QLD 4059, Australia

Country

Australia

Phone

+61731385802

Fax

+61731386030

m.kimlin@qut.edu.au

Contact person for scientific queries

Name

Shanchita Khan

Address

Institute of Health and Biomedical Innovation
Queensland University of Technology, 60 Musk Ave, Kelvin Grove, QLD 4059, Australia

Country

Australia

Phone

+61731380401

Fax

Shanchita.Khan@qimrberghofer.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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically