Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
17/09/2010
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 Helen Smith

ORCID ID

Contact details

Primary Medical Care
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
+44 (0)2380 797740
hes@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SEO148

Study information

Scientific title

Acronym

Study hypothesis

Do annual intramuscular injections of 300,000 IU of vitamin D given in the autumn reduce the risk of hip and other non-vertebral fractures sustained by men and women aged 75 yrs & over in the general practice population

Ethics approval

Approved by the South West Multi-centre Research Ethics Committee (MREC/98/6/51)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Condition

Injury, occupational diseases, poisoning: Musculoskeletal injury

Intervention

Injection containing 300,000 IU Vitamin D or placebo injection given annually over three years

Intervention type

Supplement

Phase

Not Specified

Drug names

Vitamin D

Primary outcome measures

Incidence of hip fractures, non-vertebral fractures, falls

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2000

Overall trial end date

01/03/2003

Reason abandoned

Eligibility

Participant inclusion criteria

10,000 men and women over 75 years from a general practice population living independently in own homes or sheltered accommodation

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

10000

Participant exclusion criteria

1. History of renal failure or stones
2. Hypercalcaemia
3. Active cancer
4. Medication history of oestrogen or biphosphonate within last 3 years
5. People taking daily oral vitamin supplements containing 400 IU or more of Vitamin D

Recruitment start date

01/09/2000

Recruitment end date

01/03/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Medical Care
Southampton
SO16 5ST
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 South East (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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17998225

Publication citations

  1. Results

    Smith H, Anderson F, Raphael H, Maslin P, Crozier S, Cooper C, Effect of annual intramuscular vitamin D on fracture risk in elderly men and women--a population-based, randomized, double-blind, placebo-controlled trial., Rheumatology (Oxford), 2007, 46, 12, 1852-1857, doi: 10.1093/rheumatology/kem240.

Additional files

Editorial Notes