Trivalent Chromium Treatment for Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Trivalent Chromium as a Treatment for Rheumatoid Arthritis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05545020
• Other study ID #: Trivalent chromium treatment
• Secondary ID: 040457
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 25, 2022
• Est. completion date: January 13, 2024

Study information

• Verified date: February 2024
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Trivalent chromium has shown good results in abolishing inflammation and had a successful result in treating animal model of rheumatoid arthritis. In addition to that, trivalent chromium lacks many side effects which are related to the already known medications of the disease.

So this study aims to evaluate the efficacy of trivalent chromium supplementation in rheumatoid arthritis treatment and measuring the outcomes of that in rheumatoid arthritis patients.

Description:

Rheumatoid arthritis is a debilitating autoimmune disease which is treated by medications that have many side effects. Trivalent chromium, a naturally occurring element with regulatory effects on blood sugar, has shown anti-inflammatory properties in many studies and has shown a good response at alleviation of rheumatoid arthritis in the disease animal model. For these reasons trivalent chromium should be tried in rheumatoid arthritis patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 13, 2024
• Est. primary completion date: January 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• rheumatoid arthritis

Exclusion Criteria:

• other autoimmune diseases

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Trivalent chromium versus synthetic and/ or biological DMARDs
Supplement and immunesuppressants

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Alexandria University, Egypt	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Hassouna SS, Sheta E, Zaki I, Harby SA, Allam EA. Trivalent chromium supplementation ameliorates adjuvant induced rheumatoid arthritis through up-regulation of FOXP3 and decrease in synovial Cathepsin G expression. Inflammopharmacology. 2022 Dec;30(6):2181-2195. doi: 10.1007/s10787-022-01025-8. Epub 2022 Jul 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arthritis scored by DAS28 score	DAS 28 is a score of arthritis	three months
Primary	ESR in mm/hr	lab measures for disease activity	three months
Primary	CRP mg/dL	lab measures for disease activity	three months
Primary	Radiological investigations if required (X-RAY, ultrasound, MRI, bone scan)	To assess joints and bone	three months
Secondary	Serum urea	A renal function test to exclude trivalent chromium side effects.	three months
Secondary	serum creatinine	A renal function test to exclude trivalent chromium side effects.	three months
Secondary	SGOT	A liver function test to exclude trivalent chromium side effects.	three months
Secondary	SGPT	A liver function test to exclude trivalent chromium side effects.	three months