A controlled intervention study of vitamin D supplementation on neuromuscular and psychomotor function in elderly people who fall
ISRCTN | ISRCTN53385740 |
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DOI | https://doi.org/10.1186/ISRCTN53385740 |
Secondary identifying numbers | REC00304 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 18/11/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Cameron Swift
Scientific
Scientific
King's College Hospital
East Dulwich Grove
London
SE22 8PT
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
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 | Choice reaction time and aggregate functional performance time. |
Secondary outcome measures | Fall rates. |
Overall study start date | 01/04/1999 |
Completion date | 01/04/2001 |
Eligibility
Participant type(s) | Patient |
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Age group | Senior |
Sex | Both |
Target number of participants | Not provided at time of registration |
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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
King's College Hospital
London
SE22 8PT
United Kingdom
SE22 8PT
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive London
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/05/2002 | Yes | No |