Dietary Phytoestrogens as Risk Factors for Systemic Lupus Erythematosus
NCT ID: NCT03421184
Last Updated: 2023-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
63 participants
INTERVENTIONAL
2018-11-26
2023-06-26
Brief Summary
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Detailed Description
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The study is an observational, monocentric, preliminary study aiming at determining if estrogenic isoflavones can be risk factors for SLE. No treatment is planned. The intervention will be the collection of extra blood and urine samples on SLE subjects and on autoimmune and healthy counterparts.
Consumers are unintentionally exposed to estrogenic isoflavones through their diet. A dietary habit enquiry and a 48h dietary recall (based on pharmacokinetics of soy-isoflavones) will be proposed to the included subjects. Urine and blood samples collected during a clinical visit performed 7 days after the onset of previous menses will be analyzed for soy isoflavones, metabolites and for enterolactone both free and conjugated. Free estradiol will be assayed as a potential confounding risk factor.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Patient with Systemic Lupus Erythematosus
30 women with SLE
blood sample
25 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
urine sample
10 ml
food questionnaire
dietary habit enquiry and a 48h dietary
hair
lock of hair
Patients with other autoimmune diseases
20 patients with rheumatoid arthritis, 20 patients with autoimmune thrombocytopenia
blood sample
25 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
urine sample
10 ml
food questionnaire
dietary habit enquiry and a 48h dietary
hair
lock of hair
Healthy control
30 healthy control women
blood sample
25 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
urine sample
10 ml
food questionnaire
dietary habit enquiry and a 48h dietary
hair
lock of hair
Interventions
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blood sample
25 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
urine sample
10 ml
food questionnaire
dietary habit enquiry and a 48h dietary
hair
lock of hair
Eligibility Criteria
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Inclusion Criteria
* Premenopausal women over 18
* with acute LEAD flare
* having given informed consent
* and being covered by social insurance.
* Group : Autoimmune diseases :
* Premenopausal women of matching age with other autoimmune disease,
* having given informed consent
* and being covered by social insurance.
* Healthy controls :
* Premenopausal women over 18,
* having given informed consent,
* and being covered by social insurance.
Exclusion Criteria
* Human Immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis C virus (HBV) sero-positivity;
* pregnant or lactating women;
* menopausal women;
* patient in remission of quiescent phase of her pathology;
* Healthy controls :
* HIV, HCV or HBV sero-positivity;
* pregnant or lactating women;
* menopausal women.
18 Years
FEMALE
Yes
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Jean-François VIALLARD, Prof
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Locations
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CHU de Bordeaux - service de médecine interne
Pessac, , France
Countries
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Other Identifiers
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CHUBX 2017/18
Identifier Type: -
Identifier Source: org_study_id
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