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Homocysteine and B vitamins in cognitive impairment
DOI 10.1186/ISRCTN94410159
ClinicalTrials.gov identifier
EudraCT number
Public title Homocysteine and B vitamins in cognitive impairment
Scientific title
Serial number at source TP212
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
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Cognitive Impairment
Participants - inclusion criteria Subjects with mild cognitive impairment 70 years and older
Participants - 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
Anticipated start date 01/04/2004
Anticipated end date 31/03/2006
Status of trial Completed
Patient information material
Target number of participants 300
Interventions 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.
Primary outcome measure(s) 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 measure(s) 1. Trial recruitment procedures
2. Conversion to dementia
Sources of funding 1. Medical Research Council (MRC) (UK) (TP212)
2. Charles Wolfson Charitable Trust
Trial website
Publications 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20838622
Contact name Prof  A. David  Smith
  Address Department of Pharmacology
Mansfield Rd
  City/town Oxford
  Zip/Postcode OX1 3QT
  Country United Kingdom
  Tel +44 (0)1865 271883
  Fax +44 (0)1865 271882
  Email david.smith@pharmacology.ox.ac.uk
Sponsor University of Oxford (UK)
  Address Medical Sciences Research Services
John Radcliffe Hospital
  City/town Oxford
  Zip/Postcode OX3 9DU
  Country United Kingdom
  Tel +44 (0)1865 222604
  Fax +44 (0)1865 222550
  Email michael.halsey@admin.ox.ac.uk
Date applied 03/05/2005
Last edited 15/09/2010
Date ISRCTN assigned 21/06/2005
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