| Source of record | UK Trials |
| ISRCTN | ISRCTN66376460 |
| Date ISRCTN assigned | 05/10/2001 |
| Local reference number(s) | None |
| 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) |
| Disease/condition/study domain | 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Men and women over 65 years |
| Participants - exclusion criteria | People too unwell to take part |
| Patient information material |
|
| Anticipated start date | 01/08/2001 |
| Anticipated end date | 31/07/2004 |
| Status of trial | Completed |
| 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) | Primary care contacts, self-reported days of
infection and quality of life. |
| Secondary outcome measure(s) | Antibiotic prescriptions, hospital admissions, adverse events, health service costs and
compliance. |
| Trial website | http://www.abdn.ac.uk/hsru/hta/mavis.shtml |
| Publications | Stephen A, Milne AC, Avenell A, McNeil G, for the MAVIS Group. Nutrition risk in the MAVIS Study - A comparison [Oral presentation]. Joint Nutrition Society/British Dietetic Association Meeting, Glasgow, 27-28 March 2003.
Avenell A, Milne AC, Stephen AI, for the MAVIS Trial Group. A randomised double-blind, placebo-controlled trial of the effect of vitamin and mineral supplements on morbitity from infections in men and women aged 65 years and over [Poster presentation]. BAPEN meeting, Telford 17-18 November 2004
Avenell A, Milne AC, Stephen AI, for the MAVIS Trial Group. A randomised double-blind placebo-controlled trial of the effect of vitamin and mineral supplements on morbitity from infections in men and women aged 65 years and over. [Poster presentation]. ESPEN meeting, Lisbon 11-14 September 2004.
Stephen AI, Avenell A. Vitamin and mineral supplementation to reduce infection in adults. A systematic review. [Poster presentation]. BAPEN meeting, Telford 17-18 September 2004
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16081445&query_hl=11&itool=pubmed_DocSum |
| Sources of funding | The Health Foundation |
| Sponsor name | Health Services Research Unit
University of Aberdeen |
| Sponsor details | Polwarth Building
Foresterhill
Aberdeen
United Kingdom
AB25 2ZD |
| Contact name | Dr Alison Avenell |
| Contact details | Clinical Research Fellow University of Aberdeen
Health Services Research Unit
Polwarth Building
Foresterhill
Aberdeen
United Kingdom
AB25 2ZD |
| Contact fax | +44(0) 1224 554336 |
| Contact email | a.avenell@abdn.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN66376460 |
| Date last extracted from ISRCTN register | 17/04/2008 |
