The effect of mercury exposure on inflammation in autoimmune disease
| ISRCTN | ISRCTN31359638 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31359638 |
| Secondary identifying numbers | 1 |
- Submission date
- 05/07/2016
- Registration date
- 04/08/2016
- Last edited
- 15/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Systemic lupus erythematosus (SLE) is a long-term (chronic) disease which causes widespread inflammation (swelling) in the body. SLE occurs when the immune system attacks the body’s own cells (autoimmune disease). A person’s genes alongside other factors such as diet have been connected with the development and progression of the disease. As the severity of SLE greatly varies between patients, research has been undertaken to find out how beneficial or detrimental lifestyle factors can be for different patients. There is a lot of evidence that eating oily fish can be beneficial for patients with SLE, as it is rich in n-3 fatty acids (omega 3), which has been shown to decrease inflammation and reduce disease activity in SLE. Whilst fish provide beneficial nutrients to the human diet they also contain tiny amounts of mercury. There is limited research on the effect mercury may have in SLE. Mercury concentrations vary between fish and are largely dictated by the size and species of fish. There is some evidence that benefits of the n-3 fatty acids present in fish that we eat outweighs any negative effects from any mercury also present. The aim of this study is to investigate the effect of mercury and n-3 fatty acids on the production of biomarkers (natural chemical indicators) of inflammation, using blood cells taken from people with SLE and from those without SLE, in order to find out if the n-3 fatty acids will have an anti-inflammatory effect over and above any pro-inflammatory effect that mercury may have on the cells.
Who can participate?
Adults with SLE and healthy adults of the same age and gender.
What does the study involve?
All participants provide a small blood sample. From each sample, the immune cells are removed and treated in the laboratory with docosahexaenoic acid or eicosapentaenoic acid (two types of omega 3) or a vehicle control (dummy solution). After 24 hours, the cells are treated with mercury or a vehicle control (dummy) for another 24 hours. The amount of natural chemical indicators of inflammation produced by the cells are then measured.
What are the possible benefits and risks of participating?
There are no direct benefits involved with participating in this study. There is a small risk of bruising following removal of blood, however researchers conducting this procedure are trained and experienced.
Where is the study run from?
Ulster University (UK)
When is the study starting and how long is it expected to run for?
May 2015 to December 2016
Who is funding the study?
Ulster University (UK)
Who is the main contact?
Dr Emeir McSorley
em.mcsorley@ulster.ac.uk
Contact information
Scientific
Centre of Molecular Biosciences
Ulster University
Cromore Road
Coleraine
BT52 1SA
United Kingdom
| Phone | +44 2870 123543 |
|---|---|
| em.mcsorley@ulster.ac.uk |
Study information
| Study design | Laboratory-based case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | ISRCTN31359638_PIS_02Mar15.doc |
| Scientific title | An in vitro study to determine the effect of mercury and n-3 fatty acids on markers of inflammation in systemic lupus erythematosus |
| Study objectives | Lymphocytes from autoimmune patients exposed to methylmercury will elicit a more pronounced pro-inflammatory effect than lymphocytes from healthy controls. |
| Ethics approval(s) | Office for Research Ethics committees Northern Ireland (ORECNI), 20/05/2015, ref: 15/NI/0062 |
| Health condition(s) or problem(s) studied | Systemic Lupus Erythematosus |
| Intervention | Twelve Systemic lupus erythematosus participants and twelve age and gender matched controls will be recruited from Northern Ireland and donate a 27mls blood samples. Peripheral blood mononuclear cells taken from all participants will be pre-treated with docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA) or vehicle control. Following incubation for 24 hours, cells will be treated with methyl mercury and LPS or vehicle control for a further 24 hours. Supernatants will be stored at -80 degrees Celsius. Pro-inflammatory cytokines will be measured in supernatants using a multiplex ELISA. |
| Intervention type | Other |
| Primary outcome measure | Pro-inflammatory cytokines secreted from peripheral blood mononuclear cells will be measured using a multiplex ELISA assay. |
| Secondary outcome measures | No secondary outcome measures. |
| Overall study start date | 20/05/2015 |
| Completion date | 01/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 12 systemic lupus erythematosus patients and 12 healthy controls |
| Key inclusion criteria | Systemic lupus erythematosus (SLE) participants: 1. Aged between 18-65 2. A diagnosis of SLE (American College of Rheumatology criteria) 3. Not currently pregnant 4. Not currently taking any n-3 fatty acid supplements Control participants: 1. Aged between 18-65 2. Free from illness 3. Not taking any medication (including non-steroidal anti-inflammatories) 4. Not currently pregnant 5. Not currently taking any n-3 fatty acid supplements |
| Key exclusion criteria | Systemic lupus erythematosus (SLE) participants: 1. Currently on high dose steroids (>10mg daily) 2. Currently suffering from an acute illness 3. Regularly consume more than 3 portions of fish per week 4. Pregnancy 5. Currently taking any n-3 fatty acid supplements Control participants: 1. Regularly consume more than 3 portions of fish per week 2. Pregnancy 3. Currently taking any n-3 fatty acid supplements |
| Date of first enrolment | 20/05/2015 |
| Date of final enrolment | 31/07/2016 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
Coleraine
BT52 1SA
United Kingdom
Sponsor information
University/education
Cromore Road
Coleraine
BT52 1SA
Northern Ireland
United Kingdom
"ROR" |
https://ror.org/01yp9g959 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 31/01/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Results will be published in a peer reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 02/03/2015 | 15/09/2016 | No | Yes | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN31359638_PIS_02Mar15.doc
- Uploaded 15/09/2016
Editorial Notes
15/09/2016: Uploaded participant information sheet
