Condition category
Nervous System Diseases
Date applied
03/03/2008
Date assigned
04/04/2008
Last edited
03/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.open-study.org.uk

Contact information

Type

Scientific

Primary contact

Dr Alan Dangour

ORCID ID

Contact details

London School of Hygiene and Tropical Medicine (LSHTM)
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7958 8133
alan.dangour@lshtm.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NO5R0009

Study information

Scientific title

Older People and Enhanced Neurocognitive function study

Acronym

OPEN

Study hypothesis

Older people are at increased risk of vitamin B12 deficiency, which can lead to severe neurocognitive deficit (e.g., progressive weakness, vision and hearing loss, impairment in communication and co-ordination). The aim of the present study is to assess whether increased dietary intake of crystalline vitamin B12 will improve nerve function and cognitive function in older people with defined low vitamin B12 status. Demonstrating that vitamin B12 dependant nerve and cognitive function impairment is present even in individuals without clinical symptoms will have considerable public health significance.

Ethics approval

Cambridgeshire 4 REC, 30/04/2008

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information can be found at: http://openstudy.lshtm.ac.uk/participant.pdf

Condition

Nerve and cognitive function

Intervention

Daily nutritional supplement of 1 mg vitamin B12 versus placebo. The total duration of treatment is 12 months for both arms. Longer term follow-up may be the subject of a separate protocol.

Intervention type

Supplement

Phase

Not Applicable

Drug names

Vitamin B12 supplementation

Primary outcome measures

Amplitude of tibial motor evoked responses and tibial nerve conduction velocity, measured at 12 months.

Secondary outcome measures

1. Cognitive function: immediate recall, prospective memory, letter search/cancellation, verbal fluency, symbol digit modalities, simple and choice reaction time
2. Timed up and go
3. Psychological health (mood) using the 30-item General Health Questionnaire (GHQ-30)
4. Height and weight
5. History of myocardial infarction (MI) and stroke (reported hospitalisation)

All outcomes measured at 12 months.

Overall trial start date

01/07/2008

Overall trial end date

01/11/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy volunteers
2. Aged 75 years and over, either sex
3. Defined low B12 status (greater than 107 pmol/l and less than 210 pmol/l)
4. No previous history of diabetes or dementia

Participant type

Healthy volunteer

Age group

Senior

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Pre-existing type I or type II diabetes at baseline
2. Pre-existing dementia at baseline
3. Currently consuming vitamin B12 on a daily basis
4. Mini-Mental State Examination (MMSE) score less than 24 at baseline screen
5. Very low B12 (below 107 pmol/l - Beckman Coulter assay)
6. B12 levels above 210 pmol/l
7. Anaemic
8. History of epilepsy
9. Those with implanted metallic devices such as a pacemaker
10. Alcoholics

Recruitment start date

01/07/2008

Recruitment end date

01/11/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

London School of Hygiene and Tropical Medicine (LSHTM)
London
WC1E 7HT
United Kingdom

Sponsor information

Organisation

London School of Hygiene and Tropical Medicine (LSHTM) (UK)

Sponsor details

Keppel Street
London
WC1E 7HT
United Kingdom
-
penny.ireland@lshtm.ac.uk

Sponsor type

Hospital/treatment centre

Website

http://www.lshtm.ac.uk/

Funders

Funder type

Government

Funder name

Food Standards Agency (UK)

Alternative name(s)

FSA

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21396086
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26135351

Publication citations

  1. Protocol

    Dangour AD, Allen E, Clarke R, Elbourne D, Fasey N, Fletcher AE, Letley L, Richards M, Whyte K, Mills K, Uauy R, A randomised controlled trial investigating the effect of vitamin B12 supplementation on neurological function in healthy older people: the Older People and Enhanced Neurological function (OPEN) study protocol [ISRCTN54195799]., Nutr J, 2011, 10, 22, doi: 10.1186/1475-2891-10-22.

  2. Results

    Dangour AD, Allen E, Clarke R, Elbourne D, Fletcher AE, Letley L, Richards M, Whyte K, Uauy R, Mills K, Effects of vitamin B-12 supplementation on neurologic and cognitive function in older people: a randomized controlled trial, Am J Clin Nutr, 2015.

Additional files

Editorial Notes