A randomised controlled study of the effect of dietary sodium modification on asthma control
| ISRCTN | ISRCTN80771653 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80771653 |
| Secondary identifying numbers | Version 1 |
- Submission date
- 02/08/2005
- Registration date
- 10/08/2005
- Last edited
- 07/05/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Andrew Fogarty
Scientific
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 |
|---|---|
| andrew.fogarty@nottingham.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/01/2006 |
| Completion date | 01/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Dept of Epidemiology and Public Health
Nottingham
NG5 1PB
United Kingdom
NG5 1PB
United Kingdom
Sponsor information
University of Nottingham (UK)
University/education
University/education
University Park
Nottingham
NG7 2RP
England
United Kingdom
| Phone | +44 (0)115 9515679 |
|---|---|
| paul.cartledge@nottingham.ac.uk | |
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Charity
Asthma UK (UK) (2005 grant)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Asthma UK, Asthma + Lung UK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 15/07/2008 | Yes | No |
