Therapeutic effect of vitamin D on renal manifestation of systemic lupus erythematosus

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 50

Inclusion Criteria

Inclusion Criteria:
aged 18-65 years; baseline SLEDAI score <= 4; estimated glomerular filtration rate more than 15 ml/min/1.73m2; proteinuria > 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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proteinuria. Timepoint: every 2 month. Method of measurement: U/A.;GFR. Timepoint: every 2 month. Method of measurement: U/A.

Secondary Outcome Measures

Name	Time	Method
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.