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| ID | Type | Description | Link |
|---|---|---|---|
| IRCT2013030912762N1 | Registry Identifier | Iranian Registry of Clinical Trials |
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The purpose of this study is to determine whether calcitriol is effective in the treatment of lupus nephritis.
Systemic lupus erythematosus (SLE) is an autoimmune disease and renal involvement represent one of the most common manifestations of it . On the other hand, there is evidence that vitamin D and its analogs have known immunosuppressant properties and profound effects on glomerular mesangial cell proliferation. Moreover much literature such as animal studies suggests it as a therapeutic intervention in autoimmune disease. The investigators plan to conduct a double blind randomized control clinical trial to study effects of calcitriol on progress and activity of lupus nephritis. Fifty patients with clinically quiescent SLE and biopsy-proven glomerulonephritis will be recruited. They will be treated with calcitriol for 1 year. Proteinuria, renal function, lupus disease activity, serum inflammatory markers will be monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | Patients will receive calcitriol at a fixed dose daily. |
|
| control group | Active Comparator | Patients will receive placebo daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| calcitriol | Drug | Patients will receive calcitriol at a fixed dose of 0.25 µg (one oral pearl) daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in proteinuria | baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| risk of lupus flare | baseline and 12 months | |
| change in renal function | based on the American College of Rheumatology renal response criteria | baseline and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alireza Amir Maafi, MD Student | Contact | 00989376036481 | alireza.am427@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Banafsheh ghavidel parsa, MD | Guilan University of Medical Sciences, Iran | Study Chair |
| Alireza Amir Maafi, MD Student | Student Research Committee, Guilan University of Medical Sciences, Rasht, Iran | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Razi hospital | Recruiting | Rasht | Gilan Province | Iran |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D008181 | Lupus Nephritis |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D002117 | Calcitriol |
| ID | Term |
|---|---|
| D004100 | Dihydroxycholecalciferols |
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
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| placebo | Drug | Patients will receive placebo similar to intervention (shape, color and design) 1 oral unit daily. |
|
| change in serum inflammatory markers | baseline and 12 months |
| change in Systemic Lupus Erythematosus Disease Activity Index score | baseline and 12 months |
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002776 |
| Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |