Condition category
Respiratory
Date applied
26/04/2006
Date assigned
15/05/2006
Last edited
31/05/2007
Prospective/Retrospective
Retrospectively 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 Seif Shaheen

ORCID ID

Contact details

Imperial College London
Respiratory Epidemiology Group
National Heart and Lung Institute
St Mary's Campus
Norfolk Place
London
W2 1PG
United Kingdom
+44 (0)207 594 0948
s.shaheen@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0534164211

Study information

Scientific title

Acronym

SELINA (SELenium IN Asthma)

Study hypothesis

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

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

Study design

Randomised, double-blind, placebo-controlled trial (parallel design)

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

SelenoPrecise

Primary outcome measures

Asthma-related quality of life

Secondary outcome measures

1. Lung function
2. Asthma symptom scores
3. Peak flow
4. Bronchodilator usage

Overall trial start date

01/05/2002

Overall trial end date

01/05/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Asthma symptoms in last month
2. Prescribed inhaled steroids in last six months
3. Not taking selenium supplements

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200 (100 in each arm)

Participant 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

Recruitment start date

01/05/2002

Recruitment end date

01/05/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Imperial College London
London
W2 1PG
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Chief Research Officer for Public Health
Department of Health
Room 716 Wellington House
135-155 Waterloo Road
London
SE1 8UG
United Kingdom
+44 (0)207 972 1347
william.maton-howarth@dh.gsi.gov.uk

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

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).

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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/entrez/query.fcgi?cmd=retrieve&db=pubmed&list_uids=17234657

Publication citations

  1. Results

    Shaheen SO, Newson RB, Rayman MP, Wong AP, Tumilty MK, Phillips JM, Potts JF, Kelly FJ, White PT, Burney PG, Randomised, double blind, placebo-controlled trial of selenium supplementation in adult asthma., Thorax, 2007, 62, 6, 483-490, doi: 10.1136/thx.2006.071563.

Additional files

Editorial Notes