A randomised controlled study of the effect of dietary sodium modification on asthma control

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Andrew Fogarty
Scientific

Dept of Epidemiology and Public Health
University of Nottingham
Clinical Science Building
Nottingham City Hospital
Nottingham
NG5 1PB
United Kingdom

Phone	+44 (0)115 8404782
Email	andrew.fogarty@nottingham.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Low dietary sodium improves asthma control.
Ethics approval(s)	Ethics approval received from the MREC for Wales in September 2005 (ref: 05/MRE09/72).
Health condition(s) or problem(s) studied	Asthma
Intervention	Low sodium diet versus normal sodium diet.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Dietary sodium
Primary outcome measure(s)	1. Bronchial reactivity, measured at baseline visit and six weeks later 2. Autonomic function assessed by heart rate variability, measured at baseline visit and six weeks later
Key secondary outcome measure(s)	1. Peak flow rate, measured for one week before baseline visit and for the six weeks of the study 2. Symptom score, measured for one week before baseline visit and for the six weeks of the study 3. Spirometry, measured at baseline visit and six weeks later 4. Skin prick sensitivity, measured at baseline visit and six weeks later 5. Carbon monoxide, measured at baseline visit and six weeks later
Completion date	01/12/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	220
Key inclusion criteria	1. Aged 18 - 65 years, either sex 2. Asthma 3. Bronchial reactivity to methacholine
Key exclusion criteria	1. Oral steroids 2. Diuretics or drug that affects sodium 3. Current or planned pregnancy 4. Other serious illness 5. Recent exacerbation of asthma
Date of first enrolment	01/01/2006
Date of final enrolment	01/12/2007

Dept of Epidemiology and Public Health

Nottingham
NG5 1PB
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	15/07/2008		Yes	No