Active Rheumatoid Arthritis Clinical Trial
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00959036 -
Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid Arthritis
|
Phase 1/Phase 2 | |
| Completed |
NCT00913458 -
Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis
|
Phase 4 | |
| Completed |
NCT01961505 -
Topical Compound Tripterygium Wilfordii Hook F for Patients With Active Rheumatoid Arthritis
|
N/A | |
| Completed |
NCT00393471 -
Study Comparing Etanercept Plus Methotrexate to Either Etanercept or Methotrexate Alone in Rheumatoid Arthritis.
|
Phase 3 | |
| Not yet recruiting |
NCT03346590 -
Evolution of Total Energy Expenditure and Its Various Components in Active Rheumatoid Arthritis (RA)Treated With Anti-TNF Agents and Comparison With Healthy Subjects
|
N/A | |
| Terminated |
NCT02534896 -
To Evaluate The Efficacy And Safety Of Sunpharma1505 Compared With Reference1505 In Subjects With Active Rheumatoid Arthritis
|
Phase 3 | |
| Completed |
NCT03172325 -
Study to Demonstrate Non-Inferior Efficacy and Safety of CinnoRA® Versus Humira® for Treatment of Active RA
|
Phase 3 | |
| Completed |
NCT00420199 -
A Phase IIIb Study of BMS-188667 in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate
|
Phase 3 | |
| Recruiting |
NCT06456489 -
Pulse Steroid Injection in Refractory Rheumatoid Arthritis
|
Phase 3 | |
| Completed |
NCT00882024 -
Safety and Efficacy Study of Tranilast in Patients With Active Rheumatoid Arthritis (RA)
|
Phase 2 | |
| Completed |
NCT03599986 -
Clinical Efficacy and Safety of Leflunomide in Egyptian Patients With Active Rheumatoid Arthritis
|
||
| Completed |
NCT02586246 -
Long-term Treatment Study of CDP870 Self-injection in Patients With Active Rheumatoid Arthritis Who Are Participating in the Long-term Treatment Studies (Study 275-08-002 or Study 275-08-004) of CDP870
|
Phase 3 | |
| Completed |
NCT01008852 -
Study Evaluating The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis
|
Phase 2 |