The relationship between mercury and systemic lupus erythematosus
| ISRCTN | ISRCTN91649606 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91649606 |
| Secondary identifying numbers | 1 |
- Submission date
- 08/08/2014
- Registration date
- 22/09/2014
- Last edited
- 13/05/2016
- 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 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
Contact information
Scientific
Room W2046
School of Biomedical Sciences
University of Ulster
Coleraine campus
Cromore Road
Co. Londonderry
Coleraine
BT52 1SA
United Kingdom
Study information
| Study design | Cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Other |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | An investigation of the exposure to inorganic and organic mercury (HG) and its relationship with disease activity in Systemic Lupus Erythematosus |
| Study acronym | HGSLE |
| Study objectives | It is postulated that there is an association between inorganic and organic mercury exposure and the development and progression of systemic autoimmunity. |
| Ethics approval(s) | Office of Research Ethic committee Northern Ireland (ORECNI), 09/01/2015. REC Ref: 14/NI/1139 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/11/2014 |
| Completion date | 01/11/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 172 |
| Key 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 |
| Key exclusion criteria | 1. Currently pregnant 2. Have ever undergone chelation therapy |
| Date of first enrolment | 10/04/2015 |
| Date of final enrolment | 01/09/2016 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centres
BT9 7AB
United Kingdom
Londonderry
BT47 6SB
United Kingdom
Sponsor information
Government
Adelaide House
39 - 49 Adelaide Street
Belfast
BT13 3NG
United Kingdom
| Website | http://www.delni.gov.uk/ |
|---|---|
"ROR" |
https://ror.org/05w9mt194 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
13/05/2016: Ethics approval information added.
