NCT03421184

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

November 26, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2023

Completed
Last Updated

July 7, 2023

Status Verified

July 1, 2023

Enrollment Period

4.6 years

First QC Date

January 29, 2018

Last Update Submit

July 6, 2023

Conditions

Lupus ErythematosusRheumatoid ArthritisAutoimmune Thrombocytopenia

Keywords

autoimmune diseaseendocrine disruptorsisoflavoneslignansdiet exposurerisk factor

Outcome Measures

Primary Outcomes (1)

  • Quantification of different isoflavones and enterolactone

    in the blood and urine of patients and healthy controls

    At baseline (day 0)

Secondary Outcomes (1)

  • Quantification of free estradiol concentrations

    At baseline (day 0)

Study Arms (3)

Patient with Systemic Lupus Erythematosus

EXPERIMENTAL

30 women with SLE

Other: blood sampleOther: urine sampleOther: food questionnaireOther: hair

Patients with other autoimmune diseases

ACTIVE COMPARATOR

20 patients with rheumatoid arthritis, 20 patients with autoimmune thrombocytopenia

Other: blood sampleOther: urine sampleOther: food questionnaireOther: hair

Healthy control

ACTIVE COMPARATOR

30 healthy control women

Other: blood sampleOther: urine sampleOther: food questionnaireOther: hair

Interventions

blood sampleOTHER

25 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

Healthy controlPatient with Systemic Lupus ErythematosusPatients with other autoimmune diseases
urine sampleOTHER

10 ml

Healthy controlPatient with Systemic Lupus ErythematosusPatients with other autoimmune diseases
food questionnaireOTHER

dietary habit enquiry and a 48h dietary

Healthy controlPatient with Systemic Lupus ErythematosusPatients with other autoimmune diseases
hairOTHER

lock of hair

Healthy controlPatient with Systemic Lupus ErythematosusPatients with other autoimmune diseases

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux - service de médecine interne

Pessac, France

Location

MeSH Terms

Conditions

Arthritis, RheumatoidPurpura, Thrombocytopenic, IdiopathicAutoimmune Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesImmune System DiseasesPurpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jean-François VIALLARD, Prof

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2018

First Posted

February 5, 2018

Study Start

November 26, 2018

Primary Completion

June 26, 2023

Study Completion

June 26, 2023

Last Updated

July 7, 2023

Record last verified: 2023-07

Locations

FR(1)