Clinical trial NCT04315818: The Relation Between Macrophage Migration Inhibitory Factor (MIF) and 25(OH) Vitamin D3 Serum Levels in Rheumatoid Arthritis
Official title: The Relation Between Macrophage Migration Inhibitory Factor (MIF) and 25(OH) Vitamin D3 Serum Levels in Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-03-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Any patient aged 18 or older and satisfying 2010 ACR/ EULAR Rheumatoid Arthritis classification criteria will be included

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Relation Between Macrophage Migration Inhibitory Factor (MIF) and 25(OH) Vitamin D3 Serum Levels in Rheumatoid Arthritis
timeFrame: october,2022
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Doaa Kamal, Doctor
role: STUDY_CHAIR
References:
citation: Santos LL, Morand EF. The role of macrophage migration inhibitory factor in the inflammatory immune response and rheumatoid arthritis. Wien Med Wochenschr. 2006 Jan;156(1-2):11-8. doi: 10.1007/s10354-005-0243-8.
citation: Kim KW, Kim HR. Macrophage migration inhibitory factor: a potential therapeutic target for rheumatoid arthritis. Korean J Intern Med. 2016 Jul;31(4):634-42. doi: 10.3904/kjim.2016.098. Epub 2016 May 12.
citation: Llamas-Covarrubias MA, Valle Y, Navarro-Hernandez RE, Guzman-Guzman IP, Ramirez-Duenas MG, Rangel-Villalobos H, Estrada-Chavez C, Munoz-Valle JF. Serum levels of macrophage migration inhibitory factor are associated with rheumatoid arthritis course. Rheumatol Int. 2012 Aug;32(8):2307-11. doi: 10.1007/s00296-011-1951-6. Epub 2011 May 24.
citation: Ishikawa LLW, Colavite PM, Fraga-Silva TFC, Mimura LAN, Franca TGD, Zorzella-Pezavento SFG, Chiuso-Minicucci F, Marcolino LD, Penitenti M, Ikoma MRV, Sartori A. Vitamin D Deficiency and Rheumatoid Arthritis. Clin Rev Allergy Immunol. 2017 Jun;52(3):373-388. doi: 10.1007/s12016-016-8577-0.
citation: Bilsborrow JB, Doherty E, Tilstam PV, Bucala R. Macrophage migration inhibitory factor (MIF) as a therapeutic target for rheumatoid arthritis and systemic lupus erythematosus. Expert Opin Ther Targets. 2019 Sep;23(9):733-744. doi: 10.1080/14728222.2019.1656718. Epub 2019 Aug 20.