Individual Study / Tabesh et al.; JMIR Res Protoc. 2016

Improving Vitamin D Status and Related Health in Young Women: The Safe-D Study - Part B

Improving Vitamin D Status and Related Health in Young Women: The Safe-D Study - Part B

Initiatives -
To measure the effectiveness of a (1) mobile-based app (behavioral) and (2) pharmacological intervention to increase circulating 25-hydroxyvitamin D (serum 25 OHD) levels and health outcomes over 4 months of intervention compared with usual care in a cohort of young women with suboptimal serum 25 OHD levels (25-75 nmol/L). Note: All published information has been collected from the article referenced in the Marker Paper box below. Therefore, there may be variations with more advanced versions of the study.
Start Year
2016
End Year
2017
Funding
This project is funded by a NHMRC project grant, APP1049065.

Design

Study design
Clinical trial cohort

Marker Paper

Tabesh M, Garland SM, Gorelik A, et al. Improving Vitamin D Status and Related Health in Young Women: The Safe-D study - Part B. JMIR Res Protoc. 2016;5(2):e80. Published 2016 May 10. doi:10.2196/resprot.5465

PUBMED 27166214

Recruitment

Sources of Recruitment
  • Individuals

Number of participants

Number of participants
78
Number of participants with biosamples

Access

Availability of data and biosamples

Data
Biosamples
Other

Timeline

Population

Participants with 25 OHD levels 25 to 75 nmol/L are invited to participate in this study. Participants are randomized to one of three groups in 1:1:1 ratio: a mobile phone-based application, vitamin D supplementation (1000 IU/day), and a control group.
Selection Criteria
Minimum age
16
Maximum age
25
Newborns
Twins
Countries
  • Australia
Ethnic Origin
Health Status
Other criteria
Participants with 25 OHD levels 25 to 75 nmol/L

Recruitment

Sources of recruitment
  • General population

Number of participants

Number of participants
78
Number of participants with biosamples
Data Collection Event
To measure the effectiveness of a (1) mobile-based app (behavioral) and (2) pharmacological intervention to increase circulating 25-hydroxyvitamin D (serum 25 OHD) levels and health outcomes over 4 months of intervention compared with usual care in a cohort of young women with suboptimal serum 25 OHD levels (25-75 nmol/L).
Start Date
2016
End Date
2017
Data sources
  • Mobile data collection
    • Mobile phone
    • Smartphone
    • Smartphone apps