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
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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesFractures 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) studiedMusculoskeletal injury due to nutritional deficiency
Interventioni. Vitamin D supplementation with IM ergocalciferol
ii. Matched placebo
Intervention typeOther
Primary outcome measureChoice reaction time and aggregate functional performance time.
Secondary outcome measuresFall rates.
Overall study start date01/04/1999
Completion date01/04/2001

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteriaElderly patients over the age of 65 years who have had a fall and are Vitamin D deficient
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/04/1999
Date of final enrolment01/04/2001

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

King's College Hospital
London
SE22 8PT
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2002 Yes No