Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000972729
Ethics application status
Not yet submitted
Date submitted
29/08/2013
Date registered
2/09/2013
Date last updated
2/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving Vitamin D status and related health in young women: The Safe-D study – Part B
Scientific title
Females aged between 16 and 25 years residing in Victoria, Australia, with 25 OHD levels between 25-74 nmol/L randomised to a behavioural intervention group (receiving the Safe-D m-Health mobile-based app), a pharmacological intervention (receiving Vitamin D3, 1000IU, daily by mouth) or a control group (general advice in the form of a pamphlet) for a period of 12 months, aiming to determine the effectiveness of the behavioural intervention to improve 25 OHD levels.
Secondary ID [1] 283078 0
Nil
Universal Trial Number (UTN)
Trial acronym
Safe-D
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin D deficiency 289917 0
Condition category
Condition code
Metabolic and Endocrine 290284 290284 0 0
Other metabolic disorders
Public Health 290339 290339 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3-arm trial comparing the effectiveness of a behavioural intervention with a pharmacological intervention and a control group to improve 25 OHD levels in young women at 4 months and 12 months.
The two intervention groups are:
- a pharmacological intervention group, receiving 1000 IU Vitamin D3, daily, oral consumption, for 12 months; weekly reminders will be sent to participants to take the tablets; compliance will be measured at 4 months and 12 months with a manual medication count.
- a behavioural intervention group, receiving a mobile-based app that provides both personalised and general advice about methods to improve Vitamin D levels, for 12 months; the app will be provided to participants and they will be informed on the ways it can be used; usage will be monitored though use of the app will be at the participants' discretion.
Intervention code [1] 287794 0
Treatment: Other
Intervention code [2] 287841 0
Behaviour
Comparator / control treatment
1 control group, receiving a pamphlet from SunSmart, explaining methods to improve Vitamin D levels
Control group
Active

Outcomes
Primary outcome [1] 290317 0
Measure the effectiveness of a (1) behavioural and (2) a pharmacological intervention to increase circulating 25 OHD levels, compared with usual care; a blood test will be performed to obtain this information and tested using a highly sensitive assay, liquid chromatography mass spectrometry (LC-MS)
Timepoint [1] 290317 0
4 months
Secondary outcome [1] 304298 0
Compare effectiveness of the two interventions to increase circulating 25 OHD levels; a blood test will be performed to obtain this information and tested using a highly sensitive assay, liquid chromatography mass spectrometry (LC-MS)
Timepoint [1] 304298 0
12 months
Secondary outcome [2] 304299 0
Measure compliance to the interventions by: manual medication count for those in the pharmacological intervention group; measuring app usage in the behavioural intervention group
Timepoint [2] 304299 0
4 months; 12 months
Secondary outcome [3] 304300 0
Measure changes in UV exposure and 'SunSmart' behaviour; this will be measured using a UV dosimeter, worn by particpants' for 14 days
Timepoint [3] 304300 0
4 months; 12 months

Eligibility
Key inclusion criteria
Residing in Victoria, Australia
Own and use a smartphone
25 OHD levels between 25 and 75 nmol/L
Minimum age
16 Years
Maximum age
25 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Currently taking Vitamin D supplements over 800 IU daily
Unable to give informed consent
Currently pregnant, breastfeeding or planning to conceive during the study timeframes
Plan to move outside of Victoria during the study
Have ever had a melanoma or 1st degree relative diagnosed with melanoma
Health problems that may put participants at greater risk, or that may confound study results (sun sensitivity conditions, malabsorption conditions)

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)
Participant will be allocated using opaque envelopes, prepared by a statistician external to the study. Block allocation will be used. Both researcher and participant will not know the group the participant will be allocated to until the time of allocation. The researcher will be blinded to the endpoints throughout the duration of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block stratified randomisation (Stratum 1: 25 OHD - 25-49 nmol/L; Stratum 2: 25 OHD 50-75nmol/L).
Allocation sequence determined by statistician external to the study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size was determined through an extensive literature review which found an increased 25 OHD concentration of ~1–2 nmol/L for each 100 IU per day of supplemental vitamin D. Assuming average supplementation of 1000 IU vitamin D/day, we expect changes in 25 OHD concentration of ~10-20 nmol/L in the pharmacological intervention group. A sample size of 62 per arm at 4 months (corresponding to 78 per arm at baseline) will give us 85% power to detect a difference between groups in the change in vitamin D level of 15 nmol/L (assuming a standard deviation of 25 nmol/L and total level of significance of 0.05), using intention-to-treat (ITT) analysis to test Hypothesis 1. This gives us 80% power to detect a 15 nmol/L difference in per protocol analysis, assuming 85% adhere to the protocol.

To test Hypothesis 2, we expect to be able to include 48 participants per arm (n = 56 for ITT analysis) in the 12-month per protocol analyses (accounting for attrition and non-compliance), giving us 80% power (85% in ITT) at 5% significance level to detect a 9-10 nmol/L difference in change from baseline between the two intervention arms (assuming a lower S.D. of 20 nmol/L due to seasonal matching).

Main analyses will be conducted on an intention-to-treat basis to compare the intervention arms against the control group at 4 and 12 months, using various imputation strategies to account for missing data arising from sample attrition.
Due to the possible protocol violations (e.g, non-compliance with the prescribed treatment), secondary per protocol analysis designed to adjust for non-compliance will be undertaken at 4 and 12 months and results will be compared to the ITT analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2014
Actual
Date of last participant enrolment
Anticipated
31/12/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
234
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1454 0
Royal Melbourne Hospital - City campus - Parkville

Funding & Sponsors
Funding source category [1] 287853 0
Government body
Name [1] 287853 0
National Health and Medical Research Council (NHMRC)
Country [1] 287853 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Grattan Street,
Parkville
Vic 3052
Country
Australia
Secondary sponsor category [1] 286582 0
None
Name [1] 286582 0
Address [1] 286582 0
Country [1] 286582 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289794 0
Melbourne Health HREC
Ethics committee address [1] 289794 0
Office of Research
Level 6 East
Royal Melbourne Hospital
Grattan Street
Parkille
Vic 3052
Ethics committee country [1] 289794 0
Australia
Date submitted for ethics approval [1] 289794 0
27/08/2013
Approval date [1] 289794 0
Ethics approval number [1] 289794 0
2013.215

Summary
Brief summary
The Safe-D study aims to determine the effectiveness of a mobile-based intervention to improve vitamin D levels in a cohort of young women, aged 16 to 25 years, residing in Victoria.
The effectiveness of the mobile-based app will be compared with standard vitamin D supplementation (1000 IU daily, by mouth, capsule form) and general advice (in the form of a pamphlet).

The study team hypothesise that the behavioural intervention will be as effective in correcting mild vitamin D deficiency within this cohort at 4 months as the standard pharmocological treatment.
Trial website
To be activated upon commencement of study
http://www.safedstudy.org/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42334 0
Prof John D Wark
Address 42334 0
Level 4 Clinical Sciences Building Department of Medicine (Royal Melbourne Hospital) The University of Melbourne Parkville Vic 3052
Country 42334 0
Australia
Phone 42334 0
+61 3 9342 7109
Fax 42334 0
Email 42334 0
jdwark@unimelb.edu.au
Contact person for public queries
Name 42335 0
Ms Karen Gillett
Address 42335 0
Level 4 Clinical Sciences Building Department of Medicine (Royal Melbourne Hospital) The University of Melbourne Parkville Vic 3052
Country 42335 0
Australia
Phone 42335 0
+61 3 9035 5178
Fax 42335 0
Email 42335 0
karen.gillett@unimelb.edu.au
Contact person for scientific queries
Name 42336 0
Prof John D Wark
Address 42336 0
Level 4 Clinical Sciences Building Department of Medicine (Royal Melbourne Hospital) The University of Melbourne Parkville Vic 3052
Country 42336 0
Australia
Phone 42336 0
+61 3 9342 7109
Fax 42336 0
Email 42336 0
jdwark@unimelb.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
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