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
Protocol serial number	N/A
Sponsor	Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Funder	NHS Asthma National Research and Development Programme (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof John Britton
Scientific

Division of Respiratory Medicine
University of Nottingham
Clinical Sciences Building
City Hospital
Nottingham
NG5 1PB
United Kingdom

Phone	+44 (0)115 840 4765
Email	john.britton@nottingham.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	1. Clinical control 2. Quality of life 3. Use of health care resources 4. Reductions in requirement for inhaled steroids
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/09/2000

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	All
Target sample size at registration	24
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

Division of Respiratory Medicine

Nottingham
NG5 1PB
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2003		Yes	No