Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
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
Query!
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.
Query!
Secondary ID [1]
283078
0
Nil
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Safe-D
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Vitamin D deficiency
289917
0
Query!
Condition category
Condition code
Metabolic and Endocrine
290284
290284
0
0
Query!
Other metabolic disorders
Query!
Public Health
290339
290339
0
0
Query!
Health promotion/education
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
287794
0
Treatment: Other
Query!
Intervention code [2]
287841
0
Behaviour
Query!
Comparator / control treatment
1 control group, receiving a pamphlet from SunSmart, explaining methods to improve Vitamin D levels
Query!
Control group
Active
Query!
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)
Query!
Assessment method [1]
290317
0
Query!
Timepoint [1]
290317
0
4 months
Query!
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)
Query!
Assessment method [1]
304298
0
Query!
Timepoint [1]
304298
0
12 months
Query!
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
Query!
Assessment method [2]
304299
0
Query!
Timepoint [2]
304299
0
4 months; 12 months
Query!
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
Query!
Assessment method [3]
304300
0
Query!
Timepoint [3]
304300
0
4 months; 12 months
Query!
Eligibility
Key inclusion criteria
Residing in Victoria, Australia
Own and use a smartphone
25 OHD levels between 25 and 75 nmol/L
Query!
Minimum age
16
Years
Query!
Query!
Maximum age
25
Years
Query!
Query!
Sex
Females
Query!
Can healthy volunteers participate?
Yes
Query!
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)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
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.
Query!
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.
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Safety/efficacy
Query!
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
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
3/02/2014
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
31/12/2014
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
234
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
1454
0
Royal Melbourne Hospital - City campus - Parkville
Query!
Funding & Sponsors
Funding source category [1]
287853
0
Government body
Query!
Name [1]
287853
0
National Health and Medical Research Council (NHMRC)
Query!
Address [1]
287853
0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Query!
Country [1]
287853
0
Australia
Query!
Primary sponsor type
University
Query!
Name
The University of Melbourne
Query!
Address
Grattan Street,
Parkville
Vic 3052
Query!
Country
Australia
Query!
Secondary sponsor category [1]
286582
0
None
Query!
Name [1]
286582
0
Query!
Address [1]
286582
0
Query!
Country [1]
286582
0
Query!
Ethics approval
Ethics application status
Not yet submitted
Query!
Ethics committee name [1]
289794
0
Melbourne Health HREC
Query!
Ethics committee address [1]
289794
0
Office of Research
Level 6 East
Royal Melbourne Hospital
Grattan Street
Parkille
Vic 3052
Query!
Ethics committee country [1]
289794
0
Australia
Query!
Date submitted for ethics approval [1]
289794
0
27/08/2013
Query!
Approval date [1]
289794
0
Query!
Ethics approval number [1]
289794
0
2013.215
Query!
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.
Query!
Trial website
To be activated upon commencement of study
http://www.safedstudy.org/
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
42334
0
Prof John D Wark
Query!
Address
42334
0
Level 4 Clinical Sciences Building Department of Medicine (Royal Melbourne Hospital) The University of Melbourne Parkville Vic 3052
Query!
Country
42334
0
Australia
Query!
Phone
42334
0
+61 3 9342 7109
Query!
Fax
42334
0
Query!
Email
42334
0
[email protected]
Query!
Contact person for public queries
Name
42335
0
Ms Karen Gillett
Query!
Address
42335
0
Level 4 Clinical Sciences Building Department of Medicine (Royal Melbourne Hospital) The University of Melbourne Parkville Vic 3052
Query!
Country
42335
0
Australia
Query!
Phone
42335
0
+61 3 9035 5178
Query!
Fax
42335
0
Query!
Email
42335
0
[email protected]
Query!
Contact person for scientific queries
Name
42336
0
Prof John D Wark
Query!
Address
42336
0
Level 4 Clinical Sciences Building Department of Medicine (Royal Melbourne Hospital) The University of Melbourne Parkville Vic 3052
Query!
Country
42336
0
Australia
Query!
Phone
42336
0
+61 3 9342 7109
Query!
Fax
42336
0
Query!
Email
42336
0
[email protected]
Query!
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.
Download to PDF