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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Patients will receive calcitriol at a fixed dose of 0.25 µg (one oral pearl) daily.
Patients will receive placebo similar to intervention (shape, color and design) 1 oral unit daily.
Razi hospital
Rasht, Gilan Province, Iran
RECRUITINGchange in proteinuria
Time frame: baseline and 12 months
risk of lupus flare
Time frame: baseline and 12 months
change in renal function
based on the American College of Rheumatology renal response criteria
Time frame: baseline and 12 months
change in serum inflammatory markers
Time frame: baseline and 12 months
change in Systemic Lupus Erythematosus Disease Activity Index score
Time frame: baseline and 12 months
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