Rheumatoid Arthritis Clinical Trial
— ISOLEDOfficial title:
Dietary Phytoestrogens in Blood and Urine of Female Patient With Acute Systemic Lupus Erythematosus
Verified date | July 2023 |
Source | University Hospital, Bordeaux |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study aims at determining if dietary phytoestrogens can be risk factors for Systemic Lupus Erythematosus (SLE). Dietary enquiry and phytoestrogens measurements will be performed in blood and urine of patients with SLE in an active phase of the disease, in patient with other autoimmune diseases and in healthy volunteers. Subjects will be premenopausal women and when possible at a define stage of the menstrual cycle. Free blood estradiol will be assayed as a confounding risk factor.
Status | Completed |
Enrollment | 63 |
Est. completion date | June 26, 2023 |
Est. primary completion date | June 26, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Group : Systemic Lupus Erythematosus : - 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: - Group Systemic Lupus Erythematosus and group autoimmune diseases - 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. |
Country | Name | City | State |
---|---|---|---|
France | CHU de Bordeaux - service de médecine interne | Pessac |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quantification of different isoflavones and enterolactone | in the blood and urine of patients and healthy controls | At baseline (day 0) | |
Secondary | Quantification of free estradiol concentrations | in the blood and urine of patients and healthy controls | At baseline (day 0) |
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