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ISRCTN
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ISRCTN66376460
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ClinicalTrials.gov identifier
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Public title
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A randomised double-blind placebo-controlled trial of the effect of vitamin and mineral supplements on morbidity from infections in men and women over 65 years
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Scientific title
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Acronym
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MAVIS (Mineral and Vitamin Intervention Trial)
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Serial number at source
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None
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Study hypothesis
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Infections are common in older people. The vitamin and mineral status of many older people may be sub-optimal, influencing immunity and risk of infection. We examined whether vitamin and mineral
supplementation influences self-reported infections, health service use, quality of life and is cost-effective in people aged 65 years and older, over one year. The MAVIS trial was a randomised, placebo-controlled trial, with blinding of participants, outcome assessors
and investigators until analyses were completed.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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None
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Participants - inclusion criteria
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Men and women over 65 years
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Participants - exclusion criteria
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People too unwell to take part
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Anticipated start date
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01/08/2001
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Anticipated end date
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31/07/2004
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Status of trial
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Completed
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Patient information material
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Target number of participants
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910
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Interventions
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Daily vitamin and mineral supplement, approximating the Reference Nutrient Intake (RNI) of 11 vitamins and five minerals, or a matching placebo in a double blind design for 1 year
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Primary outcome measure(s)
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Primary care contacts, self-reported days of
infection and quality of life.
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Secondary outcome measure(s)
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Antibiotic prescriptions, hospital admissions, adverse events, health service costs and
compliance.
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Sources of funding
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The Health Foundation (UK)
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Trial website
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http://www.abdn.ac.uk/hsru/hta/mavis.shtml
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Publications
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Results in:
1. http://www.ncbi.nlm.nih.gov/pubmed/16081445
2. http://www.ncbi.nlm.nih.gov/pubmed/17474991
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Contact name
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Dr
Alison
Avenell
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Address
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Clinical Research Fellow University of Aberdeen
Health Services Research Unit
Polwarth Building
Foresterhill
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City/town
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Aberdeen
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Zip/Postcode
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AB25 2ZD
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Country
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United Kingdom
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Fax
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+44(0) 1224 554336
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Email
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a.avenell@abdn.ac.uk
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Sponsor
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Health Services Research Unit, University of Aberdeen (UK)
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Address
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Polwarth Building
Foresterhill
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City/town
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Aberdeen
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Zip/Postcode
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AB25 2ZD
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Country
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United Kingdom
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Date applied
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05/10/2001
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Last edited
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21/04/2008
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Date ISRCTN assigned
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05/10/2001
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