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Trivalent Chromium Treatment for Rheumatoid Arthritis

Sponsor
Alexandria University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05545020
Collaborator
(none)
100
Enrollment
2
Arms
13
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Trivalent chromium versus synthetic and/ or biological DMARDs
 Phase 2/Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Trivalent Chromium as a Treatment for Rheumatoid Arthritis Patients
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Trivalent chromium

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

Drug: Trivalent chromium versus synthetic and/ or biological DMARDs
Supplement and immunesuppressants
Other Names:
  • According to sponsor and treatments the patients are already taking in comparison

    		•
    Active Comparator: Immunesuppressants

    Synthetic and/ or biological DMARDs

    Drug: Trivalent chromium versus synthetic and/ or biological DMARDs
    Supplement and immunesuppressants
    Other Names:
  • According to sponsor and treatments the patients are already taking in comparison

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Arthritis scored by DAS28 score [Six months]

      DAS 28 is a score of arthritis

    2. ESR in mm/hr [Six months]

      lab measures for disease activity

    3. CRP mg/dL [Six months]

      lab measures for disease activity

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

      To assess joints and bone

    Secondary Outcome Measures

    1. Serum urea [Six months]

      A renal function test to exclude trivalent chromium side effects.

    2. serum creatinine [Six months]

      A renal function test to exclude trivalent chromium side effects.

    3. SGOT [Six months]

      A liver function test to exclude trivalent chromium side effects.

    4. SGPT [Six months months]

      A liver function test to exclude trivalent chromium side effects.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • rheumatoid arthritis
    Exclusion Criteria:
    • other autoimmune diseases

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Alexandria University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Sally Saad Saad Hassouna, Lecturer of Internal Medicine department, Rheumatology and Immunology Unit, Alexandria University
    ClinicalTrials.gov Identifier:
    NCT05545020
    Other Study ID Numbers:
    • Still
    First Posted:
    Sep 19, 2022
    Last Update Posted:
    Sep 19, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid
    Chromium

    Study Results

    No Results Posted as of Sep 19, 2022