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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
ISRCTN ISRCTN66376460
DOI 10.1186/ISRCTN66376460
ClinicalTrials.gov identifier
EudraCT number
Public title 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
Scientific title
Acronym MAVIS (Mineral and Vitamin Intervention Trial)
Serial number at source None
Study hypothesis 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.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Mineral & vitamin supplementation
Participants - inclusion criteria Men and women over 65 years
Participants - exclusion criteria People too unwell to take part
Anticipated start date 01/08/2001
Anticipated end date 31/07/2004
Status of trial Completed
Patient information material
Target number of participants 910
Interventions 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
Primary outcome measure(s) 1. Primary care contacts
2. Self-reported days of infection
3. Quality of life
Secondary outcome measure(s) Antibiotic prescriptions, hospital admissions, adverse events, health service costs and
compliance.
Sources of funding The Health Foundation (UK)
Trial website http://www.abdn.ac.uk/hsru/hta/mavis.shtml
Publications 1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16081445
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17474991
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20082054
Contact name Dr  Alison  Avenell
  Address Clinical Research Fellow University of Aberdeen
Health Services Research Unit
Polwarth Building
Foresterhill
  City/town Aberdeen
  Zip/Postcode AB25 2ZD
  Country United Kingdom
  Fax +44(0) 1224 554336
  Email a.avenell@abdn.ac.uk
Sponsor Health Services Research Unit, University of Aberdeen (UK)
  Address Polwarth Building
Foresterhill
  City/town Aberdeen
  Zip/Postcode AB25 2ZD
  Country United Kingdom
Date applied 05/10/2001
Last edited 07/04/2010
Date ISRCTN assigned 05/10/2001
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