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 |
| Secondary identifying numbers | None |
- Submission date
- 05/10/2001
- Registration date
- 05/10/2001
- Last edited
- 07/04/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Alison Avenell
Scientific
Scientific
Clinical Research Fellow University of Aberdeen
Health Services Research Unit
Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
United Kingdom
| a.avenell@abdn.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| 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 | 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 study start date | 01/08/2001 |
| Completion date | 31/07/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Clinical Research Fellow University of Aberdeen
Aberdeen
AB25 2ZD
United Kingdom
AB25 2ZD
United Kingdom
Sponsor information
Health Services Research Unit, University of Aberdeen (UK)
University/education
University/education
Polwarth Building
Foresterhill
Aberdeen
AB25 2ZD
Scotland
United Kingdom
"ROR" |
https://ror.org/016476m91 |
|---|
Funders
Funder type
Charity
The Health Foundation (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| 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 |
