Active Rheumatoid ArthritisPhase 4NCT04472481
Vitamin D Effect in Rheumatoid Arthritis.
A Phase 4 study testing Ergocalciferol 1.25 mg tablet in people with Active Rheumatoid Arthritis, run by Tanta University at 1 site in Egypt.
Trial summary
Regulatory T (Tregs) cells play an important role in the maintenance of immunological tolerance. It decrease in the peripheral blood of rheumatoid arthritis patients. Vitamin D has an immunomodulatory and anti-inflammatory effect in rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 33 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Active Rheumatoid Arthritis
- What is being tested?
- Ergocalciferol 1.25 mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Sep 2019to 22 Mar 2020
- Phase
- Phase 4
- 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 33 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- disease duration less than 3 years from the time of diagnosis, age more than 18 years, a diagnosis of RA according to the 2010 ACR/ EULAR Classification criteria for RA diagnosis , active disease according to DAS-28, for those receiving nonsteroidal anti-inflammatory drugs and corticosteroids, the dosage had to be stable for at least 2 weeks before screening.
Who cannot join
- Patients with allergic, and infectious diseases, patients receiving steroids for the first time within 2 weeks before the study, patients with hypercalcemia, hypercalciuria, nephrolithiasis, or neoplastic diseases were excluded from the study. We also excluded patients on any biologic therapy and patients with prior use of leflunomide, hydroxychloroquine, or sulphasalazine for more than 2 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D: Does It Help Tregs in Active Rheumatoid Arthritis Patients.
Regulatory T (Tregs) cells play an important role in the maintenance of immunological tolerance. It decrease in the peripheral blood of rheumatoid arthritis patients. Vitamin D has an immunomodulatory and anti-inflammatory effect in rheumatoid arthritis.
Vitamin D supplementation significantly enhances Tregs percentage in the peripheral blood of RA patients. So supplementation of Vit D improves rheumatoid arthritis disease activity.
Read the detailed description
Background: Regulatory T cells (Tregs) play an important role in the maintenance of immunological tolerance, so Tregs deficiency or decrease suppressor functions may be associated with development of autoimmune diseases.
Vitamin D is essential for normal bone mineralization and growth, prevention of osteopenia, osteoporosis, and nonspecific painful musculoskeletal conditions . Vitamin D is thought to have an immunomodulatory and anti-inflammatory actions, as its receptors are widely expressed in peripheral mononuclear blood cells, also its deficiency associated with several autoimmune disorders, including rheumatoid arthritis
Methods: 40 patients with active RA were randomly assigned into two groups. Group I received MTX plus hydroxychloroquine, group II received MTX and hydroxychloroquine plus vitamin D supplementation for 3 months, in addition to 30 healthy volunteers as control group. Peripheral blood Tregs were measured by Flow Cytometry.
Statistical Analysis. The collected data analyzed by SPSS software (version 16). The range, mean and standard deviation were calculated for quantitative variables. Categorical variables were expressed as number and percentages; Chi square was used as a test of their significance. Skewness, kurtosis; Shapiro-Wilk, and The Kolmogorov-Smirnov tests were used to test the normality for the data. The difference between two means was analyzed using the students (t) test (paired and unpaired samples- T tests). Significance was considered at p<0.05.
- Conditions
- Active Rheumatoid Arthritis
- Being tested
- Ergocalciferol 1.25 mg tablet
- Keywords
- Regulatory T cell, Foxp3+, vitamin D supplementation, Rheumatoid arthritis, DMARD
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ergocalciferol 1.25 mg tabletDrug
weekly 50000 IU of Vitamin D2 (Ergocalciferol 1.25 mg tablet) given orally group II
| Study group | Role | What they receive |
|---|---|---|
| group II | Other | 50000 IU of Vitamin D2 (Ergocalciferol 1.25 mg tablet) weekly for 3 months Receives: Drug: Ergocalciferol 1.25 mg tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from base line Measurement of regulatory T cells (CD4+CD25+FoxP3+) at 3 months
4 ml of heparinized blood from the subjects' peripheral blood was collected. Human peripheral blood natural regulatory T cells (Tregs) were surface stained with Mouse Anti-Human CD4 FITC (Fluorescein) conjugated Monoclonal Antibody and Mouse Anti-Human IL-2 Rα/CD25 APC (allophycocyanin) conjugated Monoclonal Antibody, followed by intracellular staining using Rabbit Anti-Human/ Mouse FoxP3 PE (phycoerythrin) conjugated Antigen Affinity-purified Monoclonal Antibody, cells were fixed and permeabilized with FoxP3 Fixation \& Permeabilization Buffer Kit. Cells were gated on lymphocytes.
Measured: base line and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start6 Sep 2019
- Primary completion22 Dec 2019
- Study completion22 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Active Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Tanta 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Souzan Ezzat Gado, Tanta University
- Investigators
- Souzan E Gado, MD, Principal investigator, LecturerHanaa S EL-banna, MD, Principal investigator, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472481
- Sponsor's protocol ID
- 33846
- Status last verified
- Jul 2020
- First submitted
- 7 Jul 2020
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang Z, Chang C, Lu Q. Epigenetics of CD4+ T cells in autoimmune diseases. Curr Opin Rheumatol. 2017 Jul;29(4):361-368. doi: 10.1097/BOR.0000000000000393.
PubMed 28362657Lan Q, Fan H, Quesniaux V, Ryffel B, Liu Z, Zheng SG. Induced Foxp3(+) regulatory T cells: a potential new weapon to treat autoimmune and inflammatory diseases? J Mol Cell Biol. 2012 Feb;4(1):22-8. doi: 10.1093/jmcb/mjr039. Epub 2011 Nov 22.
PubMed 22107826El-Banna HS, Gado SE. Vitamin D: does it help Tregs in active rheumatoid arthritis patients. Expert Rev Clin Immunol. 2020 Aug;16(8):847-853. doi: 10.1080/1744666X.2020.1805317. Epub 2020 Aug 25.
PubMed 32783547
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D: Does It Help Tregs in Active Rheumatoid Arthritis Patients.
- ClinicalTrials.gov ID
- NCT04472481
- Acronym / sponsor ID
- 33846
- Conditions
- Active Rheumatoid Arthritis
- Keywords
- Regulatory T cell, Foxp3+, vitamin D supplementation, Rheumatoid arthritis, DMARD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 6 Sep 2019 (actual)
- Primary completion
- 22 Dec 2019 (actual)
- Study completion
- 22 Mar 2020 (actual)
- First posted
- 15 Jul 2020 (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.
Regulatory T (Tregs) cells play an important role in the maintenance of immunological tolerance. It decrease in the peripheral blood of rheumatoid arthritis patients. Vitamin D has an immunomodulatory and anti-inflammatory effect in rheumatoid arthritis.
Vitamin D supplementation significantly enhances Tregs percentage in the peripheral blood of RA patients. So supplementation of Vit D improves rheumatoid arthritis disease activity.
Detailed description
Background: Regulatory T cells (Tregs) play an important role in the maintenance of immunological tolerance, so Tregs deficiency or decrease suppressor functions may be associated with development of autoimmune diseases.
Vitamin D is essential for normal bone mineralization and growth, prevention of osteopenia, osteoporosis, and nonspecific painful musculoskeletal conditions . Vitamin D is thought to have an immunomodulatory and anti-inflammatory actions, as its receptors are widely expressed in peripheral mononuclear blood cells, also its deficiency associated with several autoimmune disorders, including rheumatoid arthritis
Methods: 40 patients with active RA were randomly assigned into two groups. Group I received MTX plus hydroxychloroquine, group II received MTX and hydroxychloroquine plus vitamin D supplementation for 3 months, in addition to 30 healthy volunteers as control group. Peripheral blood Tregs were measured by Flow Cytometry.
Statistical Analysis. The collected data analyzed by SPSS software (version 16). The range, mean and standard deviation were calculated for quantitative variables. Categorical variables were expressed as number and percentages; Chi square was used as a test of their significance. Skewness, kurtosis; Shapiro-Wilk, and The Kolmogorov-Smirnov tests were used to test the normality for the data. The difference between two means was analyzed using the students (t) test (paired and unpaired samples- T tests). Significance was considered at p<0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group II | Other | Drug: Ergocalciferol 1.25 mg tablet50000 IU of Vitamin D2 (Ergocalciferol 1.25 mg tablet) weekly for 3 months |
Who may qualify
- Ages
- 33 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- disease duration less than 3 years from the time of diagnosis, age more than 18 years, a diagnosis of RA according to the 2010 ACR/ EULAR Classification criteria for RA diagnosis , active disease according to DAS-28, for those receiving nonsteroidal anti-inflammatory drugs and corticosteroids, the dosage had to be stable for at least 2 weeks before screening.
Key exclusion criteria (1 listed)
- Patients with allergic, and infectious diseases, patients receiving steroids for the first time within 2 weeks before the study, patients with hypercalcemia, hypercalciuria, nephrolithiasis, or neoplastic diseases were excluded from the study. We also excluded patients on any biologic therapy and patients with prior use of leflunomide, hydroxychloroquine, or sulphasalazine for more than 2 months.
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 |
|---|---|---|
| Ergocalciferol 1.25 mg tabletweekly 50000 IU of Vitamin D2 (Ergocalciferol 1.25 mg tablet) given orally group II | Drug | group II |
Primary outcome
change from base line Measurement of regulatory T cells (CD4+CD25+FoxP3+) at 3 months
Time frame: base line and after 3 months
4 ml of heparinized blood from the subjects' peripheral blood was collected. Human peripheral blood natural regulatory T cells (Tregs) were surface stained with Mouse Anti-Human CD4 FITC (Fluorescein) conjugated Monoclonal Antibody and Mouse Anti-Human IL-2 Rα/CD25 APC (allophycocyanin) conjugated Monoclonal Antibody, followed by intracellular staining using Rabbit Anti-Human/ Mouse FoxP3 PE (phycoerythrin) conjugated Antigen Affinity-purified Monoclonal Antibody, cells were fixed and permeabilized with FoxP3 Fixation \& Permeabilization Buffer Kit. Cells were gated on lymphocytes.
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 15 Jul 2020.
- Background: PubMed 28362657Wang Z, Chang C, Lu Q. Epigenetics of CD4+ T cells in autoimmune diseases. Curr Opin Rheumatol. 2017 Jul;29(4):361-368. doi: 10.1097/BOR.0000000000000393.
- Background: PubMed 22107826Lan Q, Fan H, Quesniaux V, Ryffel B, Liu Z, Zheng SG. Induced Foxp3(+) regulatory T cells: a potential new weapon to treat autoimmune and inflammatory diseases? J Mol Cell Biol. 2012 Feb;4(1):22-8. doi: 10.1093/jmcb/mjr039. Epub 2011 Nov 22.
- Derived from this study: PubMed 32783547El-Banna HS, Gado SE. Vitamin D: does it help Tregs in active rheumatoid arthritis patients. Expert Rev Clin Immunol. 2020 Aug;16(8):847-853. doi: 10.1080/1744666X.2020.1805317. Epub 2020 Aug 25.
- 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.
Souzan E Gado, MD principal investigator
Lecturer
Hanaa S EL-banna, MD principal investigator
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ergocalciferol 1.25 mg tablet in people with Active Rheumatoid Arthritis, run by Tanta 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 15 Jul 2020. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
change from base line Measurement of regulatory T cells (CD4+CD25+FoxP3+) at 3 months (time frame: base line and after 3 months). 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 NCT04472481, which also lists 3 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 15 Jul 2020.