Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Emeir McSorley
ORCID ID
Contact details
Centre of Molecular Biosciences
Ulster University
Cromore Road
Coleraine
BT52 1SA
United Kingdom
+44 2870 123543
em.mcsorley@ulster.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
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
Acronym
Study hypothesis
Lymphocytes from autoimmune patients exposed to methylmercury will elicit a more pronounced pro-inflammatory effect than lymphocytes from healthy controls.
Ethics approval
Office for Research Ethics committees Northern Ireland (ORECNI), 20/05/2015, ref: 15/NI/0062
Study design
Laboratory-based case-control study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Other
Trial type
Other
Patient information sheet
See additional files
Condition
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
Phase
Drug names
Primary outcome measures
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 trial start date
20/05/2015
Overall trial end date
01/12/2016
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
12 systemic lupus erythematosus patients and 12 healthy controls
Participant 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
Recruitment start date
20/05/2015
Recruitment end date
31/07/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Ulster University
Cromore Road
Coleraine
BT52 1SA
United Kingdom
Funders
Funder type
University/education
Funder name
Ulster University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Results will be published in a peer reviewed journal.
Intention to publish date
31/01/2017
Participant level data
Not expected to be available
Results - basic reporting
Publication summary
Publication citations
Additional files
- ISRCTN31359638_PIS_02Mar15.doc Uploaded 15/09/2016