Contact information
Type
Scientific
Primary contact
Dr Andrew Fogarty
ORCID ID
Contact details
Dept of Epidemiology and Public Health
University of Nottingham
Clinical Science Building
Nottingham City Hospital
Nottingham
NG5 1PB
United Kingdom
+44 (0)115 8404782
andrew.fogarty@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 1
Study information
Scientific title
Acronym
Study hypothesis
Low dietary sodium improves asthma control.
Ethics approval
Ethics approval received from the MREC for Wales in September 2005 (ref: 05/MRE09/72).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Asthma
Intervention
Low sodium diet versus normal sodium diet.
Intervention type
Drug
Phase
Not Specified
Drug names
Dietary sodium
Primary outcome measure
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
Secondary outcome measures
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
Overall trial start date
01/01/2006
Overall trial end date
01/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 - 65 years, either sex
2. Asthma
3. Bronchial reactivity to methacholine
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
220
Participant 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
Recruitment start date
01/01/2006
Recruitment end date
01/12/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Dept of Epidemiology and Public Health
Nottingham
NG5 1PB
United Kingdom
Sponsor information
Organisation
University of Nottingham (UK)
Sponsor details
University Park
Nottingham
NG7 2RP
United Kingdom
+44 (0)115 9515679
paul.cartledge@nottingham.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Asthma UK (UK) (2005 grant)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/18451321
Publication citations
-
Results
Pogson ZE, Antoniak MD, Pacey SJ, Lewis SA, Britton JR, Fogarty AW, Does a low sodium diet improve asthma control? A randomized controlled trial., Am. J. Respir. Crit. Care Med., 2008, 178, 2, 132-138, doi: 10.1164/rccm.200802-287OC.