Condition category
Musculoskeletal Diseases
Date applied
08/08/2014
Date assigned
22/09/2014
Last edited
13/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Systemic lupus erythematosus (SLE) is an inflammatory condition where the immune system targets the body's own tissues. SLE is thought to arise from interplay between genetic and environmental factors. One such environmental factor that has been proposed is exposure to mercury. This study aims to find the relationship between exposure to mercury and disease activity in people with SLE.

Who can participate?
SLE patients between the age of 18-65 can participate in this study.

What does the study involve?
The patients are required to provide a blood, urine and hair sample as well as being assessed for disease activity and damage. Patients will also complete questionnaires detailing dental history, lifestyle choices and eating habits. This will be for a duration of one year. Each patient will only be assessed on one occasion.

What are the possible benefits and risks of participating?
Information obtained from this study will contribute to the understanding of SLE. There are no foreseen risks to the patient.

Where is the study run from?
The University of Ulster in collaboration with the rheumatology clinics of the National Health Service (NHS) will conduct this research.

When is the study starting and how long is it expected to run for?
November 2014 to November 2016

Who is funding the study?
Northern Ireland Department of Employment and Learning (DEL)

Who is the main contact?
Mr William Crowe
Crowe-w@email.ulster.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Emeir McSorley

ORCID ID

Contact details

Room W2046
School of Biomedical Sciences
University of Ulster
Coleraine campus
Cromore Road
Co. Londonderry
Coleraine
BT52 1SA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

An investigation of the exposure to inorganic and organic mercury (HG) and its relationship with disease activity in Systemic Lupus Erythematosus

Acronym

HGSLE

Study hypothesis

It is postulated that there is an association between inorganic and organic mercury exposure and the development and progression of systemic autoimmunity.

Ethics approval

Office of Research Ethic committee Northern Ireland (ORECNI), 09/01/2015. REC Ref: 14/NI/1139

Study design

Cross-sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Other

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Systemic lupus erythematosus

Intervention

Patients will be assessed for disease activity and damage, and exposure to inorganic and methyl mercury. Fatty acids will be measured in the blood of the patients. They will have their dental amalgams quantified and will complete a dental history questionnaire as well as a lifestyle and food consumption questionnaires. Recruitment and sampling will be for a duration of one year. Each patient will only be assessed on one occasion.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The primary aim is to investigate the relationship between concentrations of mercury in hair (reflecting organic mercury exposure) and urine (reflecting inorganic mercury exposure) and disease activity in systemic lupus erythematosus patients. These will be assessed at one timepoint for each patient. Hair mercury will be measured using atomic absorption spectrometry. Urinary mercury will be analysed using cold vapour atomic fluorescence spectrometry. Disease activity will be measured using the revised systemic lupus activity measure (SLAM-R), the British Isles Lupus Assessment Group (BILAG), and the Safety of Estrogen in Lupus Erythematosus National Assessment –Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI).
Disease-associated damage will be measured using the Systemic Lupus International Collaborative Clinics (SLICC) American College of Rheumatology (ACR) index.

Secondary outcome measures

The secondary aims are to investigate if genes related to how an individual absorbs or excretes mercury will have an impact on hair and urinary mercury concentrations and disease activity. Furthermore, this study will investigate if exposure to mercury impacts on markers of inflammation. These will be assessed at one timepoint for each patient. Genotyping will be completed using PCR. Markers of inflammation will be measured using ELISA.

Overall trial start date

01/11/2014

Overall trial end date

01/11/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. A positive diagnosis of SLE using the American College of Rheumatology (ACR) diagnosis criteria
2. Patients must be aged between 18-65

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

172

Participant exclusion criteria

1. Currently pregnant
2. Have ever undergone chelation therapy

Recruitment start date

10/04/2015

Recruitment end date

01/09/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Belfast City Hospital
Lisburn Road
BT9 7AB
United Kingdom

Trial participating centre

Altnagelvin Area Hospital
Glenshane Road
Londonderry
BT47 6SB
United Kingdom

Sponsor information

Organisation

The Department of Employment and Learning (DEL) (UK)

Sponsor details

Adelaide House
39 - 49 Adelaide Street
Belfast
BT13 3NG
United Kingdom

Sponsor type

Government

Website

http://www.delni.gov.uk/

Funders

Funder type

Government

Funder name

The Department of Employment and Learning (DEL) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

13/05/2016: Ethics approval information added.