Health Condition 1: null- SYSTEMIC LUPUS ERYTHEMATOSUS Health Condition 2: M321- Systemic lupus erythematosus withorgan or system involvement
Conditions
Interventions
Intervention1: Vitamin D: 60,000IU weekly once for 12 weeks,followed by 2000IU daily for 9 months.
Control Intervention1: Placebo: 60,000IU weekly once for 12 weeks,followed by 2000IU daily for 1 year
Sponsors
Bidyut Kumar Das
Eligibility
Inclusion criteria
Inclusion criteria: 1)Patients fulfilling the SLICC criteria for SLE. 2)Baseline 25(OH)D concentration 3)Stable disease at screening , defined by SLEDAI score of 4)If on corticosteroids, the dose must be 5)If on other immunomodulators like azathioprine,mycophenolate,leflunomide, hydroxycholoroquine and methotrexate dose must be stable for 3 months prior to screening and at study entry. 6)Patients giving informed consent for participating in the trial.
Exclusion criteria
Exclusion criteria: 1)Pregnancy 2)Overlap syndrome. 3)SLE with renal failure or on dialysis. 4)Hypercalcemia 5)Hyperparathyroidism 6)History of Renal calculi 7)Patients with active tuberculosis 8)Patients with viral infections like HIV, HBV, HCV. 9)Patients with sepsis 10)Baseline 25(OH)D concentration >40ng/ml. 11)Not willing to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in SLEDAI scoreTimepoint: Assessed every 3 months from treatment initiation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in level of anti ds DNATimepoint: Assessed every 3 months from treatment initiation.;Change in serum C3 levelTimepoint: Assessed every 3 months from treatment initiation.;Change in serum C4 levelTimepoint: Assessed every 3 months from treatment initiation.;Change in the levels of IFNαTimepoint: Assessed every 3 months from treatment initiation. | — |
Countries
India
Contacts
Public ContactManoranjan Behera
S.C.B. Medical College
Outcome results
None listed