Condition category
Mental and Behavioural Disorders
Date applied
03/05/2005
Date assigned
21/06/2005
Last edited
14/09/2015
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 A. David Smith

ORCID ID

Contact details

Department of Pharmacology
Mansfield Rd
Oxford
OX1 3QT
United Kingdom
+44 (0)1865 271883
david.smith@pharmacology.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

TP212

Study information

Scientific title

Homocysteine and B vitamins in cognitive impairment

Acronym

VITACOG

Study hypothesis

Lowering plasma total homocysteine by increasing B vitamin supplements will slow the rate of shrinkage of the brain in subjects with mild cognitive impairment and reduce the rate of decline in cognitive test scores

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

Treatment

Patient information sheet

Condition

Cognitive Impairment

Intervention

Two groups: placebo and treated with folic acid (0.8mg), vitamin B12 (0.5mg) and vitamin B6 (20mg) for two years.
Follow-up: telephone memory test at 30 months after start.

Intervention type

Supplement

Phase

Not Specified

Drug names

Folic acid, vitamin B12 and vitamin B6

Primary outcome measures

1. Rate of shrinkage of whole brain and or brain regions assessed by volumetric MRI
2. Changes in performance on a variety of cognitive tests

Secondary outcome measures

1. Trial recruitment procedures
2. Conversion to dementia

Overall trial start date

01/04/2004

Overall trial end date

31/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Subjects with mild cognitive impairment 70 years and older

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Dementia
2. Treatment with drugs for dementia
3. Active cancer
4. Vitamin B12 injections
5. Stroke within last three months
6. Inability to undergo Magnetic Resonance Imaging (MRI) scan

Recruitment start date

01/04/2004

Recruitment end date

31/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford
Oxford
OX1 3QT
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Medical Sciences Research Services
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 222604
michael.halsey@admin.ox.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) (TP212)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Charles Wolfson Charitable Trust

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

2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20838622
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25877495

Publication citations

  1. Results

    Smith AD, Smith SM, de Jager CA, Whitbread P, Johnston C, Agacinski G, Oulhaj A, Bradley KM, Jacoby R, Refsum H, Homocysteine-lowering by B vitamins slows the rate of accelerated brain atrophy in mild cognitive impairment: a randomized controlled trial., PLoS ONE, 2010, 5, 9, e12244, doi: 10.1371/journal.pone.0012244.

  2. Results

    Jernerén F, Elshorbagy AK, Oulhaj A, Smith SM, Refsum H, Smith AD, Brain atrophy in cognitively impaired elderly: the importance of long-chain ω-3 fatty acids and B vitamin status in a randomized controlled trial, Am J Clin Nutr, 2015 , 102, 1, 215-221, doi: 10.3945/ajcn.114.103283.

Additional files

Editorial Notes