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
Trial registered on ANZCTR


Registration number
ACTRN12617000927325
Ethics application status
Approved
Date submitted
19/06/2017
Date registered
27/06/2017
Date last updated
27/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving vitamin D status and related health in young women (part-A)–cross-section study
Scientific title
Improving vitamin D status and related health in young women (Part A)-cross-sectional study
Secondary ID [1] 292223 0
NHMRC Project Grant APP1049065
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal health 303718 0
Mood/mental health 303719 0
Cardiovascular health 303721 0
Condition category
Condition code
Public Health 303093 303093 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Investigate the association of circulating 25 OHD levels with
Musculoskeletal health
Mental health
Cardiovascular health
Intervention code [1] 298384 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302474 0
Association of circulating 25 OHD levels with muscle function
Muscle function measured by using Leonardo jumping mechanography
Timepoint [1] 302474 0
single assessment
Primary outcome [2] 302476 0
Association of circulating 25 OHD levels with weight
Timepoint [2] 302476 0
single assessment
Secondary outcome [1] 336120 0
This is a composite secondary outcome: Measure the relationship between 25 OHD levels and UV exposure under Australian conditions, examining both the overall dose and timing of sun exposure
UV exposure was assessed using a wearable UV dosimeter
Timepoint [1] 336120 0
single assessment
Secondary outcome [2] 336204 0
This is primary outcome: Association of circulating 25 OHD levels with mental health
Assessed by using a validated PHQ-9 questionnaire
Timepoint [2] 336204 0
Single assessment
Secondary outcome [3] 336207 0
This is primary outcome: Association of circulating 25 OHD levels with body composition
Body composition measured by DEXA scan
Timepoint [3] 336207 0
Single assessment
Secondary outcome [4] 336208 0
Association of circulating 25 OHD levels with allergy symptoms
Allergy data collected by questionnaire which was designed for the study
Timepoint [4] 336208 0
Single assessment
Secondary outcome [5] 336211 0
Association of circulating 25 OHD levels with bone density
Bone density measured by DEXA scan
Timepoint [5] 336211 0
Single measurement
Secondary outcome [6] 336212 0
Association of circulating 25 OHD levels with bone turnover markers, obtained from blood test
Timepoint [6] 336212 0
Single assessment

Eligibility
Key inclusion criteria
Female
16-25yrs
Living in Victoria, Australia
Provide informed verbal and written consent
Minimum age
16 Years
Maximum age
25 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnant or breastfeeding
Plan to move within 2 months of verbal consent

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/04/2014
Date of last participant enrolment
Anticipated
Actual
27/11/2015
Date of last data collection
Anticipated
Actual
27/11/2015
Sample size
Target
468
Accrual to date
Final
411
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 296763 0
Government body
Name [1] 296763 0
NHMRC
Country [1] 296763 0
Australia
Primary sponsor type
Individual
Name
Prof John D Wark
Address
Department of Medicine, Royal Melbourne Hospital, University of Melbourne, Parkville, VIC, 3052
Country
Australia
Secondary sponsor category [1] 295747 0
Individual
Name [1] 295747 0
Dr Nicola Reavley
Address [1] 295747 0
Level 5, 207 Bouverie Street, The University of Melbourne, VIC 3010
Country [1] 295747 0
Australia
Secondary sponsor category [2] 295749 0
Individual
Name [2] 295749 0
A/Prof Marie Pirotta
Address [2] 295749 0
Department of General Practice, The University of Melbourne, 200 Berkeley Street, Carlton VIC 3053
Country [2] 295749 0
Australia
Secondary sponsor category [3] 295750 0
Individual
Name [3] 295750 0
Prof George Varigos
Address [3] 295750 0
PO Box 2129, Royal Melbourne Hospital, Parkville VIC 3050
Country [3] 295750 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297990 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 297990 0
Royal Melbourne Hospital, Parkville, VIC
Ethics committee country [1] 297990 0
Australia
Date submitted for ethics approval [1] 297990 0
02/03/2013
Approval date [1] 297990 0
25/03/2013
Ethics approval number [1] 297990 0
2013.007

Summary
Brief summary
The part A of the Safe-D study involves recruitment of participants into a cross-sectional study in order to investigate the association of vitamin D (25-OHD) levels with clinical health indices and related laboratory measures: musculoskeletal health (bone density, bone turnover markers, muscle function); mood/mental health; body composition and weight; and atopic/allergic symptoms. This study recruited 411 young healthy female aged 16 to 25 years old and living in Victoria, Australia through Facebook advertisement. Wide range of data were collected through completing on line survey questionnaires, attending site visit and wearing of a UV dosimeter.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75674 0
Prof John D Wark
Address 75674 0
Department of Medicine, Royal Melbourne Hospital, University of Melbourne, Parkville, VIC, 3052
Country 75674 0
Australia
Phone 75674 0
+61 3 9342 7109
Fax 75674 0
Email 75674 0
[email protected]
Contact person for public queries
Name 75675 0
Ms Marjan Tabesh
Address 75675 0
Department of Medicine, Royal Melbourne Hospital, University of Melbourne, Parkville, VIC, 3052
Country 75675 0
Australia
Phone 75675 0
+61 451664159
Fax 75675 0
Email 75675 0
[email protected]
Contact person for scientific queries
Name 75676 0
Prof John D Wark
Address 75676 0
Department of Medicine, Royal Melbourne Hospital, University of Melbourne, Parkville, VIC, 3052
Country 75676 0
Australia
Phone 75676 0
+61 3 9342 7109
Fax 75676 0
Email 75676 0
[email protected]

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.