NCT05545020

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Dec 2022

Shorter than P25 for phase_2 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

December 25, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2024

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

1.1 years

First QC Date

September 9, 2022

Last Update Submit

February 4, 2024

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (4)

  • Arthritis scored by DAS28 score

    DAS 28 is a score of arthritis

    three months

  • ESR in mm/hr

    lab measures for disease activity

    three months

  • CRP mg/dL

    lab measures for disease activity

    three months

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

    To assess joints and bone

    three months

Secondary Outcomes (4)

  • Serum urea

    three months

  • serum creatinine

    three months

  • SGOT

    three months

  • SGPT

    three months

Study Arms (2)

Trivalent chromium

ACTIVE COMPARATOR

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

Immunesuppressants

ACTIVE COMPARATOR

Synthetic and/ or biological DMARDs

Drug: Trivalent chromium versus synthetic and/ or biological DMARDs

Interventions

Trivalent chromium versus synthetic and/ or biological DMARDsDRUG

Supplement and immunesuppressants

Also known as: Pure trivalent chromium (not in the form of a compound) and treatments the patients are already taking in comparison
ImmunesuppressantsTrivalent chromium

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • rheumatoid arthritis

You may not qualify if:

  • other autoimmune diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Alexandria University, Egypt

Alexandria, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 35829940BACKGROUND

  • 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.

    PMID: 39030450DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Nuclear Receptor Subfamily 4, Group A, Member 2

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Orphan Nuclear ReceptorsDNA-Binding ProteinsProteinsAmino Acids, Peptides, and ProteinsReceptors, Cytoplasmic and Nuclear

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Internal Medicine department, Rheumatology and Immunology Unit

Study Record Dates

First Submitted

September 9, 2022

First Posted

September 19, 2022

Study Start

December 25, 2022

Primary Completion

January 13, 2024

Study Completion

January 13, 2024

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)