Trial Review

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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] 282115 0
Nil
Secondary ID [2] 287684 0
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 288608 0
Condition category
Condition code
Metabolic and Endocrine 288941 288941 0 0
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] 286716 0
Treatment: Drugs
Intervention code [2] 286717 0
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] 289069 0
Proportion of participants who achieve vitamin D sufficiency (serum 25 hydroxyvitamin D concentration of >75nmol/L) at 12 months from baseline
Timepoint [1] 289069 0
at 12 months from baseline
Secondary outcome [1] 301673 0
Vitamin D sufficiency (serum 25-hydroxyvitamin D concentration>75nmol/L) at the end of winter
Timepoint [1] 301673 0
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] 286881 0
Government body
Name [1] 286881 0
Cancer Australia
Country [1] 286881 0
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] 285672 0
None
Name [1] 285672 0
Address [1] 285672 0
Country [1] 285672 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288944 0
Human Research Ethics Committee of the Australian National University
Ethics committee address [1] 288944 0
Lower Ground Floor
Chancelry 10B
East Road
The Australian National University
Acton ACT 0200
Ethics committee country [1] 288944 0
Australia
Date submitted for ethics approval [1] 288944 0
05/04/2013
Approval date [1] 288944 0
11/06/2013
Ethics approval number [1] 288944 0

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 38446 0
Prof Robyn Lucas
Address 38446 0
National Centre for Epidemiology and Population Health
Cnr Mills and Eggleston Roads
The Australian National University
Canberra
ACT 0200
Country 38446 0
Australia
Phone 38446 0
+61 2 61253448
Fax 38446 0
Email 38446 0
robyn.lucas@anu.edu.au
Contact person for public queries
Name 38447 0
Prof Robyn Lucas
Address 38447 0
National Centre for Epidemiology and Population Health
Cnr Mills and Eggleston Roads
The Australian National University
Canberra
ACT 0200
Country 38447 0
Australia
Phone 38447 0
+61 2 61253448
Fax 38447 0
Email 38447 0
robyn.lucas@anu.edu.au
Contact person for scientific queries
Name 38448 0
Prof Robyn Lucas
Address 38448 0
National Centre for Epidemiology and Population Health
Cnr Mills and Eggleston Roads
The Australian National University
Canberra
ACT 0200
Country 38448 0
Australia
Phone 38448 0
+61 2 61253448
Fax 38448 0
Email 38448 0
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
SourceTitleYear of PublicationDOI
EmbaseComparing 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.2015https://dx.doi.org/10.1186/s12889-015-1461-7
N.B. These documents automatically identified may not have been verified by the study sponsor.