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
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
-
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.