Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Alison Avenell
ORCID ID
Contact details
Clinical Research Fellow University of Aberdeen
Health Services Research Unit
Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
a.avenell@abdn.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
None
Study information
Scientific title
Acronym
MAVIS (Mineral and Vitamin Intervention Trial)
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
Condition
Mineral & vitamin supplementation
Intervention
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
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Primary care contacts
2. Self-reported days of infection
3. Quality of life
Secondary outcome measures
Antibiotic prescriptions, hospital admissions, adverse events, health service costs and
compliance.
Overall trial start date
01/08/2001
Overall trial end date
31/07/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Men and women over 65 years
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
910
Participant exclusion criteria
People too unwell to take part
Recruitment start date
01/08/2001
Recruitment end date
31/07/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clinical Research Fellow University of Aberdeen
Aberdeen
AB25 2ZD
United Kingdom
Funders
Funder type
Charity
Funder name
The Health Foundation (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
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
Publication citations
-
Results
Avenell A, Campbell MK, Cook JA, Hannaford PC, Kilonzo MM, McNeill G, Milne AC, Ramsay CR, Seymour DG, Stephen AI, Vale LD, Effect of multivitamin and multimineral supplements on morbidity from infections in older people (MAVIS trial): pragmatic, randomised, double blind, placebo controlled trial., BMJ, 2005, 331, 7512, 324-329, doi: 10.1136/bmj.331.7512.324.
-
Results
McNeill G, Avenell A, Campbell MK, Cook JA, Hannaford PC, Kilonzo MM, Milne AC, Ramsay CR, Seymour DG, Stephen AI, Vale LD, Effect of multivitamin and multimineral supplementation on cognitive function in men and women aged 65 years and over: a randomised controlled trial., Nutr J, 2007, 6, 10, doi: 10.1186/1475-2891-6-10.
-
Results
Fearn P, Avenell A, McCann S, Milne AC, Maclennan G, , Factors influencing the participation of older people in clinical trials - data analysis from the MAVIS trial., J Nutr Health Aging, 2010, 14, 1, 51-56.