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.

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Trial registered on ANZCTR

Registration number

ACTRN12613000290796

Ethics application status

Approved

Date submitted

13/03/2013

Date registered

14/03/2013

Date last updated

18/12/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Sun Exposure and Vitamin D Supplementation for mild vitamin D insufficiency in Australian Adults

Scientific title

Comparison of sun exposure advice and vitamin D supplementation for the management of mild vitamin D deficiency in Australian adults

Secondary ID [1]

Nil

Secondary ID [2]

Nil

Universal Trial Number (UTN)

U1111-1140-5606

Trial acronym

SEDS Study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Mild vitamin D deficiency

Condition category

Condition code

Metabolic and Endocrine

Normal metabolism and endocrine development and function

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Two groups will receive vitamin D supplementation: oral cholecalciferol 600IU/day and cholecalciferol 2000IU/day. These groups will receive standard (Cancer Council) sun exposure advice

Enhanced sun exposure advice - advice to receive as much sun exposure as possible to as much exposed body surface as is practicable, without experiencing sunburn, on as many occasions as possible.

A control group will receive placebo capsules and standard sun exposure advice.

All participants will receive the intervention over a 12 month period.

Intervention code [1]

Treatment: Drugs

Intervention code [2]

Behaviour

Comparator / control treatment

Placebo gelcaps (zero cholecalciferol), one per day, orally and
standard sun exposure advice for the 12 month duration from baseline.

Standard sun exposure advice is that provided by the NSW Cancer Council - to use sun protection (Slip, Slap, Slop, Seek and Slide) if the UV Index is 3 or above

Control group

Placebo

Outcomes

Primary outcome [1]

Proportion of participants who achieve vitamin D sufficiency (serum 25 hydroxyvitamin D concentration of >75nmol/L) at 12 months from baseline

Timepoint [1]

at 12 months from baseline

Secondary outcome [1]

Vitamin D sufficiency (serum 25-hydroxyvitamin D concentration>75nmol/L) at the end of winter

Timepoint [1]

end of winter

Eligibility

Key inclusion criteria

aged 18-64 years
serum 25-hydroxyvitamin D concentration of 40-60nmol/L on routine testing
Fitzpatrick Skin type 2-4

Minimum age

18 Years

Maximum age

64 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Current supplementation with vitamin D, cod liver oil, calcium
Relevant medical conditions: hypercalcemia, sarcoidosis, kidney stones, photosensitivity diseases, hepatic or renal failure
History of melanoma, squamous cell carcinoma or more than five basal cell carcinoma in the last 5 years
Receiving phototherapy
Immobility
Pregnant or lactating

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)

Participants will be recruited through general practices and randomly assigned to one of the four study groups within each study region (Canberra, Brisbane, Melbourne, Perth). Participants will be centrally randomised. Gelcaps will be packed in identical bottles and will be identical in appearance.

The enhanced sun exposure and standard sun exposure advice will be similar in appearance but different in content.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The randomisation sequence will be generated by computer, using the function in Excel

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

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

Active, not recruiting

Date of first participant enrolment

Anticipated

1/05/2013

Actual

3/09/2013

Date of last participant enrolment

Anticipated

31/08/2016

Actual

31/08/2016

Date of last data collection

Anticipated

31/12/2017

Actual

Sample size

Target

500

Accrual to date

Final

532

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Cancer Australia

Address [1]

P.O. Box 1201, Dickson, ACT 2602, Australia

Country [1]

Australia

Primary sponsor type

University

Name

National Centre for Epidemiology and Population Health

Address

Cnr Mills and Eggleston Roads,
The Australian National University
Canberra
ACT 2600

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee of the Australian National University

Ethics committee address [1]

Lower Ground Floor 
 Chancelry 10B
 East Road
 The Australian National University
 Acton ACT 0200

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/04/2013

Approval date [1]

11/06/2013

Ethics approval number [1]

Summary

Brief summary

Vitamin D deficiency is common in Australia. But Australia has high skin cancer incidence. While advice is given on safe sun exposure to avoid the risks of skin cancer, it is not clear how much sun exposure is required, at different locations in Australia, to maintain sufficient vitamin D levels throughout the year. This study thus addresses the following public health questions: 1). Can safe patterns and doses of sunlight exposure achieve and maintain vitamin D adequacy with no vitamin D supplementation? and 2). How does sun exposure advice calibrate against 2 different doses of vitamin D3 supplementation to manage mild vitamin D deficiency? We will recruit 228 Australian adults aged 18-64 years who have been diagnosed with mild vitamin D deficiency on routine testing (25(OH)D of 40-60nmol/L) in each of four regions in Australia - Canberra, Melbourne, Brisbane, Perth. Participants will be randomly allocated to one of four groups receiving different types of sun exposure advice and supplementation. Outcomes will be the proportion of participants who are vitamin D sufficient at 12 months, and at the end of winter, the time when vitamin D levels are usually lowest.

Trial website

www.sedsstudy.org

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Robyn Lucas

Address

National Centre for Epidemiology and Population Health
Cnr Mills and Eggleston Roads
The Australian National University
Canberra
ACT 0200

Country

Australia

Phone

+61 2 61253448

Fax

robyn.lucas@anu.edu.au

Contact person for public queries

Name

Robyn Lucas

Address

National Centre for Epidemiology and Population Health
Cnr Mills and Eggleston Roads
The Australian National University
Canberra
ACT 0200

Country

Australia

Phone

+61 2 61253448

Fax

robyn.lucas@anu.edu.au

Contact person for scientific queries

Name

Robyn Lucas

Address

National Centre for Epidemiology and Population Health
Cnr Mills and Eggleston Roads
The Australian National University
Canberra
ACT 0200

Country

Australia

Phone

+61 2 61253448

Fax

robyn.lucas@anu.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

Source	Title	Year of Publication	DOI
Embase	Comparing the effects of sun exposure and vitamin D supplementation on vitamin D insufficiency, and immune and cardio-metabolic function: the Sun Exposure and Vitamin D Supplementation (SEDS) Study.	2015	https://dx.doi.org/10.1186/s12889-015-1461-7

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically