Condition category
Respiratory
Date applied
02/08/2005
Date assigned
10/08/2005
Last edited
07/05/2008
Prospective/Retrospective
Prospectively 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

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 measures

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

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

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18451321

Publication citations

  1. 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.

Additional files

Editorial Notes