Condition category
Musculoskeletal Diseases
Date applied
05/07/2016
Date assigned
04/08/2016
Last edited
15/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

Ulster University

Sponsor details

Cromore Road
Coleraine
BT52 1SA
United Kingdom

Sponsor type

University/education

Website

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

Editorial Notes

15/09/2016: Uploaded participant information sheet