Condition category
Injury, Occupational Diseases, Poisoning
Date applied
19/08/2005
Date assigned
13/09/2005
Last edited
01/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Geoffrey Nicholson

ORCID ID

Contact details

Department of Clinical and Biomedical Sciences
P.O. Box 281
Geelong
3220
Australia
+61 (0)3 52267762
geoffn@barwonhealth.org.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NHMRC 251682

Study information

Scientific title

Acronym

Vital D Study

Study hypothesis

That an annual high-dose (500,000 IU) of 25-hydroxyvitamin D will reduce the rate of fractures and falls compared to placebo in older women.

Please note that as of 11/11/09 the ethics, interventions and secondary outcome fields of this trial have been updated.

Ethics approval

Added 11/11/09:
1. Barwon Health Human Research Ethics Committee (ref: 02/60)
2. University of Melbourne Human Research Ethics Committee (HREC) (ref: 0200700)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Fractures, osteoporosis and falls.

Intervention

Current information as of 11/11/09:
500,000 IU cholecalciferol or placebo

Initial information at time of registration
500,000 IU ergocalciferol or placebo annually.

Intervention type

Supplement

Phase

Not Specified

Drug names

25-hydroxyvitamin D

Primary outcome measures

Reduction of fracture rate in active arm compared to placebo.

Secondary outcome measures

1. Reduction in rate of falls
2. Improvement in mental well-being
3. Duration of independent residency
4. Reduction in total healthcare utilisation (added 11/11/09)

Substudy group are tested for various parameters of muscle strength, balance, gait and mobility.

Overall trial start date

01/04/2003

Overall trial end date

30/09/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female
2. Over 70 years old
3. High risk of falls or fracture

Participant type

Patient

Age group

Senior

Gender

Female

Target number of participants

2300

Participant exclusion criteria

1. Hypercalcemia
2. Bone-trophic medications
3. Renal disease

Recruitment start date

01/04/2003

Recruitment end date

30/09/2008

Locations

Countries of recruitment

Australia

Trial participating centre

Department of Clinical and Biomedical Sciences
Geelong
3220
Australia

Sponsor information

Organisation

The University of Melbourne (Australia)

Sponsor details

Grattan Street
Parkville
3010
Australia

Sponsor type

University/education

Website

http://www.unimelb.edu.au

Funders

Funder type

Research council

Funder name

National Health and Medical Research Council (NHMRC) (Australia) (refs: 251682, 509109 and 509310)

Alternative name(s)

NHMRC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Australia

Funder name

Commonwealth Department of Health and Ageing RC (Australia) (ref: 100505 8)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 results of recruitment strategies in http://www.ncbi.nlm.nih.gov/pubmed/19930724
2. 2010 main results in http://www.ncbi.nlm.nih.gov/pubmed/20460620
3. 2011 mental well-being results in http://www.ncbi.nlm.nih.gov/pubmed/21525520

Publication citations

  1. Results of recruitment strategies

    Sanders KM, Stuart AL, Merriman EN, Read ML, Kotowicz MA, Young D, Taylor R, Blair-Holt I, Mander AG, Nicholson GC, Trials and tribulations of recruiting 2,000 older women onto a clinical trial investigating falls and fractures: Vital D study., BMC Med Res Methodol, 2009, 9, 78, doi: 10.1186/1471-2288-9-78.

  2. Main results

    Sanders KM, Stuart AL, Williamson EJ, Simpson JA, Kotowicz MA, Young D, Nicholson GC, Annual high-dose oral vitamin D and falls and fractures in older women: a randomized controlled trial., JAMA, 2010, 303, 18, 1815-1822, doi: 10.1001/jama.2010.594.

  3. Sanders KM, Stuart AL, Williamson EJ, Jacka FN, Dodd S, Nicholson G, Berk M, Annual high-dose vitamin D3 and mental well-being: randomised controlled trial., Br J Psychiatry, 2011, 198, 5, 357-364, doi: 10.1192/bjp.bp.110.087544.

Additional files

Editorial Notes