Randomised double-blind, placebo-controlled trial of selenium supplementation in adult asthma
| ISRCTN | ISRCTN31432640 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31432640 |
| Protocol serial number | N0534164211 |
| Sponsor | Department of Health (UK) |
| Funder | 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). |
- 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
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 |
|---|---|
| s.shaheen@imperial.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double-blind, placebo-controlled trial (parallel design) |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | SelenoPrecise |
| Primary outcome measure(s) |
Asthma-related quality of life |
| Key secondary outcome measure(s) |
1. Lung function |
| Completion date | 01/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 200 |
| 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
- United Kingdom
- England
Study participating centre
Imperial College London
London
W2 1PG
United Kingdom
W2 1PG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
