Contact information
Type
Scientific
Primary contact
Prof John Britton
ORCID ID
Contact details
Division of Respiratory Medicine
University of Nottingham
Clinical Sciences Building
City Hospital
Nottingham
NG5 1PB
United Kingdom
+44 (0)115 840 4765
john.britton@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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
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
Treatment
Patient information sheet
Condition
Respiratory tract diseases: Asthma
Intervention
1. Magnesium chelate 450 mg
2. Vitamin C 1 g
3. Placebo (lactose)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/05/1998
Overall trial end date
01/09/2000
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with asthma on inhaled corticosteroids
2. Aged 18-60
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
24 (Added 18/11/09)
Participant exclusion criteria
1. Pregnancy
2. Oral steroids
3. Significant co-morbidity
4. Diuretics
Recruitment start date
01/05/1998
Recruitment end date
01/09/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Division of Respiratory Medicine
Nottingham
NG5 1PB
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Asthma National Research and Development Programme (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
2003 results in http://www.ncbi.nlm.nih.gov/pubmed/14519140
Publication citations
-
Results
Fogarty A, Lewis SA, Scrivener SL, Antoniak M, Pacey S, Pringle M, Britton J, Oral magnesium and vitamin C supplements in asthma: a parallel group randomized placebo-controlled trial., Clin. Exp. Allergy, 2003, 33, 10, 1355-1359.