None listed
Conditions
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.
Interventions
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 behav
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.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
Residing in Victoria, Australia Own and use a smartphone 25 OHD levels between 25 and 75 nmol/L
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)
Outcome results
None listed