Trivalent Chromium Treatment for Rheumatoid Arthritis

NCT ID: NCT05545020

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-25

Study Completion Date

2024-01-13

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trivalent chromium

A dietary supplement already available in market one of its known uses is to control diabetes.

Group Type ACTIVE_COMPARATOR

Trivalent chromium versus synthetic and/ or biological DMARDs

Intervention Type DRUG

Supplement and immunesuppressants

Immunesuppressants

Synthetic and/ or biological DMARDs

Group Type ACTIVE_COMPARATOR

Trivalent chromium versus synthetic and/ or biological DMARDs

Intervention Type DRUG

Supplement and immunesuppressants

Interventions

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Trivalent chromium versus synthetic and/ or biological DMARDs

Supplement and immunesuppressants

Intervention Type DRUG

Other Intervention Names

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Pure trivalent chromium (not in the form of a compound) and treatments the patients are already taking in comparison

Eligibility Criteria

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Inclusion Criteria

* rheumatoid arthritis

Exclusion Criteria

* other autoimmune diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Sally Saad Saad Hassouna

Lecturer of Internal Medicine department, Rheumatology and Immunology Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine, Alexandria University, Egypt

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 35829940 (View on PubMed)

Hassouna SS, Abdel-Moniem OM. Trivalent chromium versus baricitinib for rheumatoid arthritis treatment: first phase 2/3 randomized controlled trial, is trivalent chromium the upcoming immune-modulator? Inflammopharmacology. 2024 Oct;32(5):3163-3179. doi: 10.1007/s10787-024-01515-x. Epub 2024 Jul 19.

Reference Type DERIVED
PMID: 39030450 (View on PubMed)

Other Identifiers

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040457

Identifier Type: REGISTRY

Identifier Source: secondary_id

Trivalent chromium treatment

Identifier Type: -

Identifier Source: org_study_id

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