Trial from ANZCTR


Trial ID ACTRN12605000030673
Trial Status: Registered
Date Submitted: 19/07/2005
Date Registered: 22/07/2005
Retrospectively registered

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Public title Does Lowering Homocysteine slow the rate of memory loss in healthy older people?
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format The Effect of Homocysteine Lowering Vitamins on Cognitive Performance in healthy older people: a Randomised Controlled Trial
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
Normal Ageing 93 0
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Condition category: Condition code:
Neurological Studies of normal psychology, cognitive function and behaviour
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114 114 0 0

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Descriptions 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.
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Intervention Code:
None 33 0
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Comparator / control treatment Placebo (cellulose)
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Control group Placebo
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Primary Outcome: 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 142 0
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Timepoint: At 1 and 2 years of intervention 142 0
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Secondary Outcome: To determine if the primary outcome measure is influenced by genotype, older age, higher starting homocysteine concentration, mood state. 315 0
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Timepoint: After 1 and 2 years of intervention. 315 0
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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.
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Minimum age 65 Years
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Maximum age Not stated
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria No exclusion criteria
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Study type Interventional
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Purpose of the study Prevention
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Allocation to intervention Randomised controlled trial
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Describe the 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.
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Describe the 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.
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase
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Anticipated date of first participant enrolment 4/09/2002
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 260
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Recruitment status Completed
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Recruitment in Australia

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Recruitment outside Australia

Country: New Zealand 127 0
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State/Province: 127 0
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Funding Source: University 156 0
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Name: University of Otago; Otago Research Grant; 156 0
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Address: 156 0
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Country: New Zealand 156 0
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Funding Source: Commercial sector/Industry 157 0
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Name: Bristol Myers Squibb Mead Johnson Unrestricted Grant 157 0
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Address: 157 0
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Country: 157 0
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Primary Sponsor University
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Name: University of Otago
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Country: New Zealand
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Secondary Sponsor: Individual 111 0
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Name: Dr R Moser 111 0
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Address: 111 0
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Country: 111 0
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Secondary Sponsor: Commercial sector/Industry 112 0
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Name: Eprova AG 112 0
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Address: 112 0
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Country: 112 0
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Secondary Sponsor: Commercial sector/Industry 113 0
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Name: CH-8200 Schaffhausen for all capsules 113 0
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Address: 113 0
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Secondary Sponsor: Commercial sector/Industry 114 0
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Name: Axis-Shield, Norway for holotranscobalamin II analysis kits 114 0
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Address: 114 0
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Country: Norway 114 0
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Has the study received approval from at least one Ethics Committee? Yes
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Brief summary
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Trial website
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Trial related presentations / publications
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Jennifer McMahon
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Address: Department of Human Nutrition University of Otago P.O. Box 56 Dunedin Otago 9001
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Country: New Zealand
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Tel: +64 3 4797959
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Email: human-nutrition@otago.ac.nz
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Contact person for scientific queries
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Name: Jennifer McMahon
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Address: Department of Human Nutrition University of Otago P.O. Box 56 Dunedin Otago 9001
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Country: New Zealand
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Email: human-nutrition@otago.ac.nz
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