Primary prevention of fractures in the elderly: randomised controlled trial (RCT) of an annual injection of vitamin D in the prevention of hip and other non-vertebral fractures

ISRCTN	ISRCTN13267529
DOI	https://doi.org/10.1186/ISRCTN13267529
Protocol serial number	SEO148
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive South East (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Helen Smith
Scientific

Primary Medical Care
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Phone	+44 (0)2380 797740
Email	hes@soton.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Approved by the South West Multi-centre Research Ethics Committee (MREC/98/6/51)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Incidence of hip fractures, non-vertebral fractures, falls
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/03/2003

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	10000
Key inclusion criteria	10,000 men and women over 75 years from a general practice population living independently in own homes or sheltered accommodation
Key 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
Date of first enrolment	01/09/2000
Date of final enrolment	01/03/2003

Primary Medical Care

Southampton
SO16 5ST
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	01/12/2007		Yes	No