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Trivalent Chromium Treatment for Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Trivalent chromium versus synthetic and/ or biological DMARDs
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • rheumatoid arthritis

Exclusion Criteria:

  • other autoimmune diseases

Sites / Locations

  • Faculty of Medicine, Alexandria University, EgyptRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Trivalent chromium

Immunesuppressants

Arm Description

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

Synthetic and/ or biological DMARDs

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Serum urea
A renal function test to exclude trivalent chromium side effects.
serum creatinine
A renal function test to exclude trivalent chromium side effects.
SGOT
A liver function test to exclude trivalent chromium side effects.
SGPT
A liver function test to exclude trivalent chromium side effects.

Full Information

First Posted
September 9, 2022
Last Updated
January 31, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05545020
Brief Title
Trivalent Chromium Treatment for Rheumatoid Arthritis
Official Title
Trivalent Chromium as a Treatment for Rheumatoid Arthritis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 25, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

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

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trivalent chromium
Arm Type
Active Comparator
Arm Description
A dietary supplement already available in market one of its known uses is to control diabetes.
Arm Title
Immunesuppressants
Arm Type
Active Comparator
Arm Description
Synthetic and/ or biological DMARDs
Intervention Type
Drug
Intervention Name(s)
Trivalent chromium versus synthetic and/ or biological DMARDs
Other Intervention Name(s)
Pure trivalent chromium (not in the form of a compound) and treatments the patients are already taking in comparison
Intervention Description
Supplement and immunesuppressants
Primary Outcome Measure Information:
Title
Arthritis scored by DAS28 score
Description
DAS 28 is a score of arthritis
Time Frame
three months
Title
ESR in mm/hr
Description
lab measures for disease activity
Time Frame
three months
Title
CRP mg/dL
Description
lab measures for disease activity
Time Frame
three months
Title
Radiological investigations if required (X-RAY, ultrasound, MRI, bone scan)
Description
To assess joints and bone
Time Frame
three months
Secondary Outcome Measure Information:
Title
Serum urea
Description
A renal function test to exclude trivalent chromium side effects.
Time Frame
three months
Title
serum creatinine
Description
A renal function test to exclude trivalent chromium side effects.
Time Frame
three months
Title
SGOT
Description
A liver function test to exclude trivalent chromium side effects.
Time Frame
three months
Title
SGPT
Description
A liver function test to exclude trivalent chromium side effects.
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: rheumatoid arthritis Exclusion Criteria: other autoimmune diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sally Saad Hassouna
Email
s_hassouna151@alexmed.edu.eg
Facility Information:
Facility Name
Faculty of Medicine, Alexandria University, Egypt
City
Alexandria
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sally

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35829940
Citation
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.
Results Reference
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Trivalent Chromium Treatment for Rheumatoid Arthritis

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