Condition category
Injury, Occupational Diseases, Poisoning
Date applied
25/08/2005
Date assigned
13/09/2005
Last edited
04/10/2007
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 Elizabeth Burleigh

ORCID ID

Contact details

Department of Medicine for the Elderly
Southern General Hospital
Glasgow
G51 4TF
United Kingdom
+44 (0)141 201 1100
liz.burleigh@sgh.scot.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

001

Study information

Scientific title

Acronym

Study hypothesis

Does routine vitamin D and/or calcium supplementation reduce falls in older inpatients?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Falls, musculo-skeletal, nutrition

Intervention

Treatment group: 800 IU cholecalciferol + 1200 mg calcium
Control group: 1200 mg calcium only

Intervention type

Supplement

Phase

Not Specified

Drug names

Vitamin D

Primary outcome measures

1. Proportion of patients who fall
2. Total number of falls in the intervention and control groups

Secondary outcome measures

1. Compliance in both groups
2. Changes in functional outcomes
3. Changes in nutritional parameters
4. Vitamin D levels and change over time

Overall trial start date

07/09/2004

Overall trial end date

01/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

All inpatients >65 years old admitted to a Geriatric rehabilitation unit

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

216

Participant exclusion criteria

1. Bedbound or terminally ill
2. Known hypercalcaemia

3. Known urolithiasis
4. Renal failure on dialysis
5. ALready on routine calcium and vitamin D supplementation
6. Those patients who are nil by mouth for medical reasons.

Recruitment start date

07/09/2004

Recruitment end date

01/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Medicine for the Elderly
Glasgow
G51 4TF
United Kingdom

Sponsor information

Organisation

South Glasgow Division of Greater Glasgow Health Board (UK)

Sponsor details

Southern General Hospital
1345 Govan Road
Glasgow
G51 4TF
United Kingdom

Sponsor type

Research organisation

Website

http://www.nhsgg.org.uk

Funders

Funder type

Government

Funder name

South Glasgow Division of Greater Glasgow Health Board (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: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17656420

Publication citations

  1. Results

    Burleigh E, McColl J, Potter J, Does vitamin D stop inpatients falling? A randomised controlled trial., Age Ageing, 2007, 36, 5, 507-513, doi: 10.1093/ageing/afm087.

Additional files

Editorial Notes