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OpenTrials
Completed

NCT Number: NCT05545020

Trivalent Chromium Treatment for Rheumatoid Arthritis

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Faculty of Medicine, Alexandria University, Egypt

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • rheumatoid arthritis

Exclusion criteria

  • other autoimmune diseases

Treatment and study plan

Trivalent chromium versus synthetic and/ or biological DMARDs

Drug

Supplement and immunesuppressants

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

Primary outcomes

  1. Arthritis scored by DAS28 score

    Time frame: three months

    DAS 28 is a score of arthritis

  2. ESR in mm/hr

    Time frame: three months

    lab measures for disease activity

  3. CRP mg/dL

    Time frame: three months

    lab measures for disease activity

  4. Radiological investigations if required (X-RAY, ultrasound, MRI, bone scan)

    Time frame: three months

    To assess joints and bone

Secondary outcomes

  1. Serum urea

    Time frame: three months

    A renal function test to exclude trivalent chromium side effects.

  2. serum creatinine

    Time frame: three months

    A renal function test to exclude trivalent chromium side effects.

  3. SGOT

    Time frame: three months

    A liver function test to exclude trivalent chromium side effects.

  4. SGPT

    Time frame: three months

    A liver function test to exclude trivalent chromium side effects.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Trivalent Chromium as a Treatment for Rheumatoid Arthritis Patients

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2022
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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