Trial registered on ANZCTR


Trial ID
ACTRN12605000045617
Ethics application status
Approved
Date submitted
25/07/2005
Date registered
26/07/2005
Date last updated
26/07/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Intervention Trial to Prevent Cognitive Impairment and Depression in Older Men
Scientific title
A randomized, double blind, placebo-controlled trial of homocysteine lowering vitamins to prevent cognitive impairment and depression in older men
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive impairment 111 0
Depression 112 0
Condition category
Condition code
Neurological 130 130 0 0
Other mental health disorders
Mental Health 131 131 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single tablet, once daily, of 2 milligrams of folate, 25 milligrams of B6 and 400 micrograms of B12 for two years of study
Intervention code [1] 55 0
Prevention
Comparator / control treatment
Placebo for two years of study
Control group
Placebo

Outcomes
Primary outcome [1] 165 0
Timepoint [1] 165 0
Secondary outcome [1] 362 0
Other cognitive measures including MMSE, Clock Drawing Test, California Verbal Learning Test and Test of Attention.
Timepoint [1] 362 0
Secondary outcome [2] 363 0
Depression measures include Beck Depression Inventory and Geriatric Depression Scale.
Timepoint [2] 363 0
Secondary outcome [3] 364 0
Also changes in Quality of Life as determined by SF 36.
Timepoint [3] 364 0
Secondary outcome [4] 365 0
Laboratory measures include changes in vitamin, homocysteine and A beta protein levels.
Timepoint [4] 365 0

Eligibility
Key inclusion criteria
Men over the age of 75 years with a previous history of hypertension
Minimum age
75 Years
Maximum age
Not stated
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Significant cognitive impairment or depression at baseline, the presence of severe illness likely to cause the subject's death within 12 months, residence in a nursing home or long stay hospital,currently taking B group vitamins or food supplements and those subjects who are unable to complete the studys instruments in English.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed randomisation with sequential study numbers given to subjects and then allocation of pre-filled numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random permuted blocks by a person not involved with subjects.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 181 0
Government body
Name [1] 181 0
National Health and Medical Research Council Project Grant
Address [1] 181 0
Country [1] 181 0
Australia
Funding source category [2] 182 0
Commercial sector/Industry
Name [2] 182 0
Pfizer CVL Grant
Address [2] 182 0
Country [2] 182 0
Primary sponsor type
Government body
Name
NHMRC
Address
Country
Australia
Secondary sponsor category [1] 135 0
Individual
Name [1] 135 0
Professor Leon Flicker
Address [1] 135 0
Country [1] 135 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 947 0
University of Western Australia
Ethics committee address [1] 947 0
Ethics committee country [1] 947 0
Australia
Date submitted for ethics approval [1] 947 0
Approval date [1] 947 0
Ethics approval number [1] 947 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35477 0
Address 35477 0
Country 35477 0
Phone 35477 0
Fax 35477 0
Email 35477 0
Contact person for public queries
Name 9244 0
Prof Leon Flicker
Address 9244 0
Royal Perth Hospital
Box X2213
Perth WA 6000
Country 9244 0
Australia
Phone 9244 0
+61 8 92242750
Fax 9244 0
+61 8 92242063
Email 9244 0
leonflic@cyllene.uwa.edu.au
Contact person for scientific queries
Name 172 0
Prof Leon Flicker
Address 172 0
Royal Perth Hospital
Box X2213
Perth WA 6000
Country 172 0
Australia
Phone 172 0
+61 8 92242750
Fax 172 0
+61 8 92242063
Email 172 0
leonflic@cyllene.uwa.edu.au