NCT01863641

The Effect of Calcitriol on Progress and Activity of Lupus Nephritis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Guilan University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether calcitriol is effective in the treatment of lupus nephritis.

Detailed description

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.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	calcitriol	Patients will receive calcitriol at a fixed dose of 0.25 µg (one oral pearl) daily.
DRUG	placebo	Patients will receive placebo similar to intervention (shape, color and design) 1 oral unit daily.

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-10-01
• Completion: 2014-04-01
• First posted: 2013-05-29
• Last updated: 2013-05-29

Locations

1 site across 1 country: Iran