Rheumatoid ArthritisPhase 2/3NCT05545020
Trivalent Chromium Treatment for Rheumatoid Arthritis
A Phase 2/3 study testing Trivalent chromium versus synthetic and/ or biological DMARDs in people with Rheumatoid Arthritis, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Trivalent chromium versus synthetic and/ or biological DMARDs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Dec 2022to 13 Jan 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- rheumatoid arthritis
Who cannot join
- other autoimmune diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trivalent Chromium as a Treatment for Rheumatoid Arthritis Patients
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Trivalent chromium versus synthetic and/ or biological DMARDs
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trivalent chromium versus synthetic and/ or biological DMARDsDrug
Also called Pure trivalent chromium (not in the form of a compound) and treatments the patients are already taking in comparison
Supplement and immunesuppressants
| Study group | Role | What they receive |
|---|---|---|
| Trivalent chromium | Active comparator | A dietary supplement already available in market one of its known uses is to control diabetes. Receives: Drug: Trivalent chromium versus synthetic and/ or biological DMARDs |
| Immunesuppressants | Active comparator | Synthetic and/ or biological DMARDs Receives: Drug: Trivalent chromium versus synthetic and/ or biological DMARDs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arthritis scored by DAS28 score
DAS 28 is a score of arthritis
Measured: three months
ESR in mm/hr
lab measures for disease activity
Measured: three months
CRP mg/dL
lab measures for disease activity
Measured: three months
Radiological investigations if required (X-RAY, ultrasound, MRI, bone scan)
To assess joints and bone
Measured: three months
Secondary outcomes (4)
Serum urea
A renal function test to exclude trivalent chromium side effects.
Measured: three months
serum creatinine
A renal function test to exclude trivalent chromium side effects.
Measured: three months
SGOT
A liver function test to exclude trivalent chromium side effects.
Measured: three months
SGPT
A liver function test to exclude trivalent chromium side effects.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start25 Dec 2022
- Primary completion13 Jan 2024
- Study completion13 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Saad Saad Hassouna, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545020
- Sponsor's protocol ID
- Trivalent chromium treatment
- Other IDs
- 040457
- Status last verified
- Feb 2024
- First submitted
- 9 Sep 2022
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35829940Hassouna 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.
PubMed 39030450
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trivalent Chromium as a Treatment for Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT05545020
- Acronym / sponsor ID
- Trivalent chromium treatment
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 25 Dec 2022 (actual)
- Primary completion
- 13 Jan 2024 (actual)
- Study completion
- 13 Jan 2024 (actual)
- First posted
- 19 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trivalent chromium | Active comparator | Drug: Trivalent chromium versus synthetic and/ or biological DMARDsA dietary supplement already available in market one of its known uses is to control diabetes. |
| Immunesuppressants | Active comparator | Drug: Trivalent chromium versus synthetic and/ or biological DMARDsSynthetic and/ or biological DMARDs |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- rheumatoid arthritis
Key exclusion criteria (1 listed)
- other autoimmune diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trivalent chromium versus synthetic and/ or biological DMARDsAlso: Pure trivalent chromium (not in the form of a compound) and treatments the patients are already taking in comparisonSupplement and immunesuppressants | Drug | Immunesuppressants, Trivalent chromium |
Primary outcome
Arthritis scored by DAS28 score
Time frame: three months
DAS 28 is a score of arthritis
ESR in mm/hr
Time frame: three months
lab measures for disease activity
CRP mg/dL
Time frame: three months
lab measures for disease activity
Radiological investigations if required (X-RAY, ultrasound, MRI, bone scan)
Time frame: three months
To assess joints and bone
4 secondary outcomes
Serum urea
Time frame: three months
serum creatinine
Time frame: three months
SGOT
Time frame: three months
SGPT
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Background: PubMed 35829940Hassouna 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.
- Derived from this study: PubMed 39030450Hassouna 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Trivalent chromium versus synthetic and/ or biological DMARDs in people with Rheumatoid Arthritis, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arthritis scored by DAS28 score (time frame: three months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05545020, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.