Does vitamin D stop inpatients falling? A randomised controlled trial

ISRCTN	ISRCTN18282824
DOI	https://doi.org/10.1186/ISRCTN18282824
Protocol serial number	001
Sponsor	South Glasgow Division of Greater Glasgow Health Board (UK)
Funder	South Glasgow Division of Greater Glasgow Health Board (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Elizabeth Burleigh
Scientific

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

Phone	+44 (0)141 201 1100
Email	liz.burleigh@sgh.scot.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Does routine vitamin D and/or calcium supplementation reduce falls in older inpatients?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Falls, musculo-skeletal, nutrition
Intervention	Treatment group: 800 IU cholecalciferol + 1200 mg calcium Control group: 1200 mg calcium only
Intervention type	Supplement
Primary outcome measure(s)	1. Proportion of patients who fall 2. Total number of falls in the intervention and control groups
Key secondary outcome measure(s)	1. Compliance in both groups 2. Changes in functional outcomes 3. Changes in nutritional parameters 4. Vitamin D levels and change over time
Completion date	01/12/2005

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	216
Key inclusion criteria	All inpatients >65 years old admitted to a Geriatric rehabilitation unit
Key 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.
Date of first enrolment	07/09/2004
Date of final enrolment	01/12/2005

Department of Medicine for the Elderly

Glasgow
G51 4TF
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/09/2007		Yes	No