Systemic lupus erythematosus. Systemic lupus erythematosus with organ or system involvement
Conditions
Interventions
Intervention 1: Patients will receive calcitriol at a fixed dose of 0.25 µg (one oral pearl) daily. Intervention 2: Patients will receive placebo similar to intervention 1 oral unit daily.
Treatment - Drugs
Placebo
Patients will receive calcitriol at a fixed dose of 0.25 µg (one oral pearl) daily.
Patients will receive placebo similar to intervention 1 oral unit daily.
Sponsors
Vice- Chancellorship for Research, Guilan University of Medical Sciences, Iran
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: aged 18-65 years; baseline SLEDAI score 1 g/day (or proteinuria > 1 g/g-Cr) in 2 consecutive samples within 12 weeks despite ACE inhibitor at least 3 months; on maintenance dose of prednisolone < 15 mg/day, with or without other immunosuppressive medications; serum calcium level in normal range( 8.5-10.5 mg/dl); history of biopsy-proven lupus nephritis clinical quiescent SLE for at least 3 month; willingness to give written consent and comply with the study protocol; Exclusion Criteria: Pregnancy, lactating or childbearing potential without effective method of birth control; Severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication; History of malignancy, including leukemia and lymphoma within the past 2 years; Systemic infection requiring therapy at study entry; Any other severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension; History of drug or alcohol abuse within past 2 years; Vitamin D deficiency(25 hydroxy vitamin D less than 20ng/ml); Participation in any previous trial on vitamin D analogue; Patients receiving treatment of vitamin D and/or its analogue for other medical reasons within the past 4 weeks; Patients who are taking multivitamin supplement that contains vitamin D could be enrolled after 4 weeks of wash out period by changing to a preparation that has no vitamin D; On other investigational drugs within last 30 days; History of a psychological illness or condition such as to interfere with the patient's ability to understand the requirement of the study; History of non-compliance; Known history of sensitivity or allergy to vitamin D analogs
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proteinuria. Timepoint: every 2 month. Method of measurement: U/A.;GFR. Timepoint: every 2 month. Method of measurement: U/A. | — |
Secondary
| Measure | Time frame |
|---|---|
| Renal function. Timepoint: after 1 year. Method of measurement: based on on the ACR renal response criteria.;Activity of lupus. Timepoint: after 1 year. Method of measurement: SLEDAI.;Serum inflammatory markers. Timepoint: after 1 year. Method of measurement: routin laboratory test. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAlireza Amir Maafi
Student Research Committee, Guilan University of Medical Sciences, Iran
Outcome results
None listed