A controlled intervention study of vitamin D supplementation on neuromuscular and psychomotor function in elderly people who fall

ISRCTN	ISRCTN53385740
DOI	https://doi.org/10.1186/ISRCTN53385740
Protocol serial number	REC00304
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive London

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Cameron Swift
Scientific

King's College Hospital
East Dulwich Grove
London
SE22 8PT
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Fractures in the elderly are a major health problem with considerable costs to the NHS. Vitamin D deficiency occurs in up to 50% of housebound elderly people and is an important contributor to fractures. In addition to osteoporosis, the myopathy and neuropathy associated with Vitamin D deficiency may contribute to fractures through falls and impaired neuroprotective responses. Vitamin D supplementation can prevent peripheral fractures in older people. We hypothesize that Vitamin D supplementation in Vitamin D deficient elderly people results in improved neuromuscular and psychomotor function. This will be a collaborative, bidisciplinary investigation of patients aged over 65 years who have had a fall (identified through Accident and Emergency Department records) and are Vitamin D deficient.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Musculoskeletal injury due to nutritional deficiency
Intervention	i. Vitamin D supplementation with IM ergocalciferol ii. Matched placebo
Intervention type	Other
Primary outcome measure(s)	Choice reaction time and aggregate functional performance time.
Key secondary outcome measure(s)	Fall rates.
Completion date	01/04/2001

Participant type(s)	Patient
Age group	Senior
Sex	All
Key inclusion criteria	Elderly patients over the age of 65 years who have had a fall and are Vitamin D deficient
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/04/1999
Date of final enrolment	01/04/2001

King's College Hospital

London
SE22 8PT
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	01/05/2002		Yes	No