Randomised double-blind, placebo-controlled trial of selenium supplementation in adult asthma

ISRCTN	ISRCTN31432640
DOI	https://doi.org/10.1186/ISRCTN31432640
Secondary identifying numbers	N0534164211

Submission date: 26/04/2006
Registration date: 15/05/2006
Last edited: 31/05/2007

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 Seif Shaheen
Scientific

Imperial College London
Respiratory Epidemiology Group
National Heart and Lung Institute
St Mary's Campus
Norfolk Place
London
W2 1PG
United Kingdom

Phone	+44 (0)207 594 0948
Email	s.shaheen@imperial.ac.uk

Study information

Study design	Randomised, double-blind, placebo-controlled trial (parallel design)
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	SELINA (SELenium IN Asthma)
Study objectives	That a low intake of selenium, by increasing oxidative stress, promotes airway inflammation and worsens asthma symptoms, and that this effect can be ameliorated by supplementation with selenium, leading to a reduction in severity and even remission of asthma symptoms.
Ethics approval(s)	Approved by Greenwich Local Research Ethics Committee (LREC), main approval 21/11/01; amendments to protocol approved on 4/4/03, reference number: 82/NOV/01 and Guy's LREC main approval: 26/09/02; amendments to protocol approved on 19/11/02; 19/02/03; 15/05/03; reference number: 02/09/16
Health condition(s) or problem(s) studied	Adult asthma
Intervention	Selenium supplement 100 microgram (one tablet per day) versus placebo supplied by Pharma Nord, Denmark. The product (SelenoPrecise ™) is a yeast preparation grown in a selenium-rich medium. Placebo contains yeast only.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	SelenoPrecise
Primary outcome measure	Asthma-related quality of life
Secondary outcome measures	1. Lung function 2. Asthma symptom scores 3. Peak flow 4. Bronchodilator usage
Overall study start date	01/05/2002
Completion date	01/05/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	200 (100 in each arm)
Key inclusion criteria	1. Asthma symptoms in last month 2. Prescribed inhaled steroids in last six months 3. Not taking selenium supplements
Key exclusion criteria	1. Inability to give informed consent 2. Inability to swallow tablets 3. Pregnancy or lactation or intention to become pregnant during the trial period 3. Renal or liver disease 4. Known yeast intolerance
Date of first enrolment	01/05/2002
Date of final enrolment	01/05/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Imperial College London

London
W2 1PG
United Kingdom

Sponsor information

Department of Health (UK)
Government

Chief Research Officer for Public Health
Department of Health
Room 716 Wellington House
135-155 Waterloo Road
London
SE1 8UG
United Kingdom

Phone	+44 (0)207 972 1347
Email	william.maton-howarth@dh.gsi.gov.uk
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

Department of Health Unit Grant, which core funds our Public Health Aspects of Asthma Research Programme (Social Medicine and Health Services Research Unit (ref: 121/7418, Unit Director and grant holder Prof P Burney).

No information available

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		01/06/2007		Yes	No