Dietary magnesium or vitamin C supplementation as an adjunct to usual asthma therapy: a community-based investigation
| ISRCTN | ISRCTN20984129 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20984129 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 18/11/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof John Britton
Scientific
Scientific
Division of Respiratory Medicine
University of Nottingham
Clinical Sciences Building
City Hospital
Nottingham
NG5 1PB
United Kingdom
| Phone | +44 (0)115 840 4765 |
|---|---|
| john.britton@nottingham.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 | Treatment |
| Scientific title | |
| Study objectives | Several characteristics of a "Western" diet, including low magnesium and low vitamin C intake, have been proposed to be risk factors for the occurrence and severity of asthma. If so then these effects could be extremely important in public health terms, since the relative ease, affordability and generalisability of dietary intervention could translate even very small effects at a personal level into substantial effects in terms of primary and secondary prevention across the general population. This trial is designed to determine whether magnesium or vitamin C supplementation can yield improvements in clinical control, quality of life and use of health care resources, and reductions in requirement for inhaled steroids, in typical patients with asthma drawn from general practice populations. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Respiratory tract diseases: Asthma |
| Intervention | 1. Magnesium chelate 450 mg 2. Vitamin C 1 g 3. Placebo (lactose) |
| Intervention type | Other |
| Primary outcome measure | 1. Clinical control 2. Quality of life 3. Use of health care resources 4. Reductions in requirement for inhaled steroids |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/05/1998 |
| Completion date | 01/09/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | 24 (Added 18/11/09) |
| Key inclusion criteria | 1. Patients with asthma on inhaled corticosteroids 2. Aged 18-60 |
| Key exclusion criteria | 1. Pregnancy 2. Oral steroids 3. Significant co-morbidity 4. Diuretics |
| Date of first enrolment | 01/05/1998 |
| Date of final enrolment | 01/09/2000 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Division of Respiratory Medicine
Nottingham
NG5 1PB
United Kingdom
NG5 1PB
United Kingdom
Sponsor information
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
NHS Asthma National Research and Development Programme (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 | 01/10/2003 | Yes | No |
