Effect of sunlight exposure on vitamin D status: A pilot randomized controlled trial

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000863639
• Date of registration: 12/08/2014
• Prospective Registration: No
• Primary sponsor: Queensland University of Technology
• 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?
• Date of first enrolment: 06/08/2014
• Target sample size: 100
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12614000863639.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;

Countries of recruitment

Australia

Contacts

• Name: Ms Shanchita Khan

• Name: Prof Michael Kimlin

Key inclusion & exclusion criteria

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

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

Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

vitamin D insufficiency/deficiency;
vitamin D insufficiency/deficiency

Public Health - Epidemiology

Intervention(s)

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.

Primary Outcome(s)

25-hydroxyvitamin D concentration (25(OH)D).
Serum 25(OH)D in blood samples will me assessed using a Diasorin Liaison assay.[Baseline, 1,2,3 and 7 weeks after intervention commences]

Secondary Outcome(s)

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. [Once every day for three weeks.]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Queensland University of Technology,

Secondary Sponsor(s)

CRE in Sun and Health

Ethics review

Status: Approved
Approval date:
Contact:

HREC, Queensland University of Technology