Dietary Phytoestrogens as Risk Factors for Systemic Lupus Erythematosus (NCT03421184) | Clinical Trial Compass
CompletedNot Applicable
Dietary Phytoestrogens as Risk Factors for Systemic Lupus Erythematosus
France63 participantsStarted 2018-11-26
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study looked at phytoestrogens — things like soy and flaxseed — as possible risk factors for lupus and related autoimmune conditions; should I be changing what I eat based on that kind of research, or is the evidence still too early to act on?
2The trial measured specific compounds called isoflavones and enterolactone in people with lupus, rheumatoid arthritis, and autoimmune thrombocytopenia — do my own diet habits put me in a category worth discussing, given what this type of research is finding?
3Since this was an observational study rather than a treatment trial, what does it actually tell us about cause and effect between phytoestrogens and autoimmune disease flares, and how much weight should I give it when making decisions about my diet?
4Are there any completed studies like this one that my care team is already using to guide dietary recommendations for lupus patients, or is nutritional guidance in this area still largely based on general guidelines?
5Given that estrogen-related factors can influence autoimmune conditions like lupus, is it worth reviewing my current diet — including soy-based foods or supplements — with a specialist as part of managing my overall treatment plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quantification of different isoflavones and enterolactone