Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
REC00304
Study information
Scientific title
Acronym
Study hypothesis
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
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
Musculoskeletal injury due to nutritional deficiency
Intervention
i. Vitamin D supplementation with IM ergocalciferol
ii. Matched placebo
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Choice reaction time and aggregate functional performance time.
Secondary outcome measures
Fall rates.
Overall trial start date
01/04/1999
Overall trial end date
01/04/2001
Reason abandoned
Eligibility
Participant inclusion criteria
Elderly patients over the age of 65 years who have had a fall and are Vitamin D deficient
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/04/1999
Recruitment end date
01/04/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College Hospital
London
SE22 8PT
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive London
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
2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12009020
Publication citations
-
Results
Dhesi JK, Bearne LM, Moniz C, Hurley MV, Jackson SH, Swift CG, Allain TJ, Neuromuscular and psychomotor function in elderly subjects who fall and the relationship with vitamin D status., J. Bone Miner. Res., 2002, 17, 5, 891-897, doi: 10.1359/jbmr.2002.17.5.891.