Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/10/2001
Date assigned
05/10/2001
Last edited
07/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.abdn.ac.uk/hsru/hta/mavis.shtml

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

Sponsor information

Organisation

Health Services Research Unit, University of Aberdeen (UK)

Sponsor details

Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom

Sponsor type

University/education

Website

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes