Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
19/02/2008
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

Dr David Torgerson

ORCID ID

Contact details

University of York
Dept of Health Studies & Centre for Health Economics
Heslington
York
YO10 5DQ
United Kingdom
+44 (0)1904 434 129
djt6@york.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RCHA251

Study information

Scientific title

Acronym

Study hypothesis

To assess whether supplementation with calcium and cholecaliferol (vitamin D3) reduces the risk of fracture in women with one or more risk factors for fracture of the hip.randomised controlled trial

Ethics approval

Ethical approval for the study was obtained from the Northern and Yorkshire multicentre research ethics committee and relevant local research ethics committees.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Injury, occupational diseases, poisoning: Musculoskeletal injury

Intervention

Daily oral supplementation using 1000 mg calcium with 800 IU cholecaliferol and information leaflet on dietary calcium intake and prevention of falls, or leaflet only (control group).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

All clinical fractures

Secondary outcome measures

1. Adherence to treatment
2. Falls
3. Quality of life (measured with the 12-item short form health survey [SF-12])

Overall trial start date

09/01/2001

Overall trial end date

03/01/2004

Reason abandoned

Eligibility

Participant inclusion criteria

3314 women aged 70 and over with one or more risk factors for hip fracture:
1. Any previous fracture
2. Low body weight (less than 58 kg)
3. Smoker
4. Family history of hip fracture
5. Fair or poor self reported health

Participant type

Patient

Age group

Senior

Gender

Female

Target number of participants

3314

Participant exclusion criteria

1. Cognitive impairment
2. A life expectancy of less than six months

Recruitment start date

09/01/2001

Recruitment end date

03/01/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of York
York
YO10 5DQ
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive Northern and Yorkshire (UK)

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

Results in:
1. http://www.ncbi.nlm.nih.gov/pubmed/15860827
2. http://www.ncbi.nlm.nih.gov/pubmed/16250910

Publication citations

  1. Porthouse J, Cockayne S, King C, Saxon L, Steele E, Aspray T, Baverstock M, Birks Y, Dumville J, Francis R, Iglesias C, Puffer S, Sutcliffe A, Watt I, Torgerson DJ, Randomised controlled trial of calcium and supplementation with cholecalciferol (vitamin D3) for prevention of fractures in primary care., BMJ, 2005, 330, 7498, 1003, doi: 10.1136/bmj.330.7498.1003.

  2. Cockayne S, Torgerson DJ, A randomised controlled trial to assess the effectiveness of offering study results as an incentive to increase response rates to postal questionnaires [ISRCTN26118436]., BMC Med Res Methodol, 2005, 5, 34, doi: 10.1186/1471-2288-5-34.

Additional files

Editorial Notes