Improving Vitamin D status and related health in young women: The Safe-D study – Part B

Not Applicable

• Conditions: Vitamin D deficiency; Metabolic and Endocrine - Other metabolic disorders; Public Health - Health promotion/education

• Registration Number: ACTRN12613000972729
• Lead Sponsor: The University of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 234

Inclusion Criteria

Residing in Victoria, Australia
Own and use a smartphone
25 OHD levels between 25 and 75 nmol/

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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) [4 months]

Secondary Outcome Measures

Name	Time	Method
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) [12 months];Measure compliance to the interventions by: manual medication count for those in the pharmacological intervention group; measuring app usage in the behavioural intervention group[4 months; 12 months];Measure changes in UV exposure and 'SunSmart' behaviour; this will be measured using a UV dosimeter, worn by particpants' for 14 days [4 months; 12 months]