Trivalent Chromium Treatment for Rheumatoid Arthritis

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Trivalent chromium versus synthetic and/ or biological DMARDs

• Registration Number: NCT05545020
• Lead Sponsor: Alexandria University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-09-09
• Study First Submitted QC: 2022-09-13
• Study First Posted: 2022-09-19
• Study Start: 2022-12-25
• Primary Completion: 2024-01-13
• Study Completion: 2024-01-13
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-04
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• rheumatoid arthritis

Exclusion Criteria

• other autoimmune diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trivalent chromium	Trivalent chromium versus synthetic and/ or biological DMARDs	A dietary supplement already available in market one of its known uses is to control diabetes.
Immunesuppressants	Trivalent chromium versus synthetic and/ or biological DMARDs	Synthetic and/ or biological DMARDs

Primary Outcome Measures

Name	Time	Method
ESR in mm/hr	three months	lab measures for disease activity
Arthritis scored by DAS28 score	three months	DAS 28 is a score of arthritis
CRP mg/dL	three months	lab measures for disease activity
Radiological investigations if required (X-RAY, ultrasound, MRI, bone scan)	three months	To assess joints and bone

Secondary Outcome Measures

Name	Time	Method
Serum urea	three months	A renal function test to exclude trivalent chromium side effects.
serum creatinine	three months	A renal function test to exclude trivalent chromium side effects.
SGOT	three months	A liver function test to exclude trivalent chromium side effects.
SGPT	three months	A liver function test to exclude trivalent chromium side effects.

Trial Locations

Locations (1)

Faculty of Medicine, Alexandria University, Egypt; 🇪🇬 Alexandria, Egypt