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	https://doi.org/10.1186/ISRCTN66376460
Protocol serial number	None
Sponsor	Health Services Research Unit, University of Aberdeen (UK)
Funder	The Health Foundation (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Alison Avenell
Scientific

Clinical Research Fellow University of Aberdeen
Health Services Research Unit
Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom

Email	a.avenell@abdn.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	MAVIS (Mineral and Vitamin Intervention Trial)
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	1. Primary care contacts 2. Self-reported days of infection 3. Quality of life
Key secondary outcome measure(s)	Antibiotic prescriptions, hospital admissions, adverse events, health service costs and compliance.
Completion date	31/07/2004

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	910
Key inclusion criteria	Men and women over 65 years
Key exclusion criteria	People too unwell to take part
Date of first enrolment	01/08/2001
Date of final enrolment	31/07/2004

Clinical Research Fellow University of Aberdeen

Aberdeen
AB25 2ZD
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	06/08/2005		Yes	No
Results article	results	02/05/2007		Yes	No
Results article	results	01/01/2010		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes