Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000030673
Ethics application status
Approved
Date submitted
19/07/2005
Date registered
22/07/2005
Date last updated
22/07/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does Lowering Homocysteine slow the rate of memory loss in healthy older people?
Scientific title
The Effect of Homocysteine Lowering Vitamins on Cognitive Performance in healthy older people: a Randomised Controlled Trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Normal Ageing 93 0
Condition category
Condition code
Neurological 114 114 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised, double-blind, placebo-controlled trial. Participants >= 65 years of age with total plasma homocysteine concentrations >=13 [micro]mol/L, and normal renal function were randomised to take a single capsule once daily, containing either a placebo (cellulose) or a combination of 1mg L-Mefolinic acid (folate), 0.5 mg cyanocobalamin and 10mg pyridoxol, over 2 years.
Intervention code [1] 33 0
None
Comparator / control treatment
Placebo (cellulose)
Control group
Placebo

Outcomes
Primary outcome [1] 142 0
To determine if the rate in slowing of cognitive perfomance associated with normal ageing can be slowed by lowering homocysteine concentrations when measured by a range of tests of cognition
Timepoint [1] 142 0
At 1 and 2 years of intervention
Secondary outcome [1] 315 0
To determine if the primary outcome measure is influenced by genotype, older age, higher starting homocysteine concentration, mood state.
Timepoint [1] 315 0
After 1 and 2 years of intervention.

Eligibility
Key inclusion criteria
Total plasma homocysteine concentration >= 13 [micro]mol/L; not taking supplementary folic acid or vitamins B-12 or B-6; no prior stroke; not diabetic; no established dementia; not taking folate inhibiting medications (antiepileptics, oral hypoglycaemics, treatment for depression); have normal renal function (creatinine clearance <133 [micro]mol/L in men and < 115 [micro]mol/L in women); availble for at least 2 years.
Minimum age
65 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
Allocation to a group made by a statistician in the Dept of Social and Preventive Medicine (outside Dept Human Nutrition). Capsule packaging done in Switzerland (Eprova); code to capsules held in Switzerland, and sealed and in a locked cabinet in Dunedin till completion of the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Before randomisation the sample was stratified using the median values of age and homocysteine concentration. Random numbers between 0 and 1 were generated for each person in each of the 4 groups. Those with random numbers below the median in each group were assigned to group B, and the remainder to group A.
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
4/09/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
260
Accrual to date
Final
Recruitment outside Australia
Country [1] 127 0
New Zealand
State/province [1] 127 0

Funding & Sponsors
Funding source category [1] 156 0
University
Name [1] 156 0
University of Otago; Otago Research Grant;
Country [1] 156 0
New Zealand
Funding source category [2] 157 0
Commercial sector/Industry
Name [2] 157 0
Bristol Myers Squibb Mead Johnson Unrestricted Grant
Country [2] 157 0
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 111 0
Individual
Name [1] 111 0
Dr R Moser
Address [1] 111 0
Country [1] 111 0
Secondary sponsor category [2] 112 0
Commercial sector/Industry
Name [2] 112 0
Eprova AG
Address [2] 112 0
Country [2] 112 0
Secondary sponsor category [3] 113 0
Commercial sector/Industry
Name [3] 113 0
CH-8200 Schaffhausen for all capsules
Address [3] 113 0
Country [3] 113 0
Secondary sponsor category [4] 114 0
Commercial sector/Industry
Name [4] 114 0
Axis-Shield, Norway for holotranscobalamin II analysis kits
Address [4] 114 0
Country [4] 114 0
Norway

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35903 0
Address 35903 0
Country 35903 0
Phone 35903 0
Fax 35903 0
Email 35903 0
Contact person for public queries
Name 9222 0
Jennifer McMahon
Address 9222 0
Department of Human Nutrition
University of Otago
P.O. Box 56
Dunedin Otago 9001
Country 9222 0
New Zealand
Phone 9222 0
+64 3 4797959
Fax 9222 0
Email 9222 0
[email protected]
Contact person for scientific queries
Name 150 0
Jennifer McMahon
Address 150 0
Department of Human Nutrition
University of Otago
P.O. Box 56
Dunedin Otago 9001
Country 150 0
New Zealand
Phone 150 0
+64 3 4797959
Fax 150 0
Email 150 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.