Condition category
Respiratory
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
18/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes