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
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list