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The Relation Between Macrophage Migration Inhibitory Factor (MIF) and 25(OH) Vitamin D3 Serum Levels in Rheumatoid Arthritis

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04315818
Collaborator
(none)
70
Enrollment
30
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Rheumatoid Arthritis is a chronic debilitating inflammatory autoimmune disease of unknown etiology .

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Although the pathogenesis of Rheumatoid Arthritis is multifactorial, the contribution of cytokines is undoubtedly pivotal in the progression of the inflammatory process. One cytokine gaining recognition for its importance in the inflammatory process is Macrophage migration inhibitory factor .

    Macrophage Migration Inhibitory Factor is a multipotent cytokine involved in a broad range of functions including induction of proinflammatory mediators as well as demonstrated roles in both innate and adaptive immunity. It was originally identified in the culture medium of activated T lymphocytes as a soluble factor that inhibit random migration of macrophages .

    Macrophage Migration Inhibitory Factor induces synoviocytes expression of key proinflammatory genes including TNF, IL-1, IL-6, IL-8. Moreover, it also regulates the function of endothelial cells and B cells and is implicated in the control of synoviocytes proliferation and apoptosis via direct effects on the expression of the tumor suppressor protein P53. In Rheumatoid Arthritis, increased Macrophage Migration Inhibitory Factor levels have been demonstrated in serum, synovial fluid and tissue correlating with disease activity.

    Hydroxyapatite 25 vitamin D3 is a hormone primarily synthesized in human skin under the stimulation of ultraviolet radiation. Beyond its endocrine role in bone metabolism, Vitamin D3 is endowed with remarkable immunomodulatory properties. The effects of Vitamin D3 on the immune system include the enhancement of microbicidal ability of monocytes macrophages and the down-modulation of inflammatory cytokines produced by T lymphocytes.

    Some epidemiological studies have reported an inverse association between serum 25(OH)vitamin D3 concentrations and Rheumatoid Arthritis disease activity and severity. In addition, some studies have reported inverse correlations between serum 25(OH)vitamin D3 and circulating inflammatory markers and cytokines.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    70 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Other
    Official Title:
    The Relation Between Macrophage Migration Inhibitory Factor (MIF) and 25(OH) Vitamin D3 Serum Levels in Rheumatoid Arthritis
    Anticipated Study Start Date :
    Mar 1, 2021
    Anticipated Primary Completion Date :
    Sep 1, 2023
    Anticipated Study Completion Date :
    Sep 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    study group

    expermintal
    control group

    placebo

    Outcome Measures

    Primary Outcome Measures

    1. The Relation Between Macrophage Migration Inhibitory Factor (MIF) and 25(OH) Vitamin D3 Serum Levels in Rheumatoid Arthritis [october,2022]

      evaluate the role of Macrophage Migration Inhibitory Factor serum levels in Rheumatoid Arthritis and its relation with disease activity. evaluate the role of 25(OH)vitamin D3 serum levels in Rheumatoid Arthritis patients and its relation to disease severity. detect the relationship between Macrophage Migration Inhibitory Factor and 25(OH)vitamin D3 serum levels in Rheumatoid Arthritis patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Any patient aged 18 or older

    • satisfying 2010 ACR/ EULAR Rheumatoid Arthritis classification criteria will be included .

    Exclusion Criteria:

    • Any patient with arthritis other than Rheumatoid Arthritis

    • Individuals with other autoimmune diseases

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Chair: Doaa Kamal, Doctor, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Marwa Maher Abdelaziz, principal investegator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04315818
    Other Study ID Numbers:
    • MIF
    First Posted:
    Mar 20, 2020
    Last Update Posted:
    Jan 26, 2021
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid

    Study Results

    No Results Posted as of Jan 26, 2021