Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
18/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Cameron Swift

ORCID ID

Contact details

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

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes