A clinical trial to study the effect of Vitamin D in patients of systemic lupus erythematosus.
- Conditions
- Health Condition 1: null- SYSTEMIC LUPUS ERYTHEMATOSUSHealth Condition 2: M321- Systemic lupus erythematosus withorgan or system involvement
- Registration Number
- CTRI/2017/07/009033
- Lead Sponsor
- Bidyut Kumar Das
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1)Patients fulfilling the SLICC criteria for SLE.
2)Baseline 25(OH)D concentration <20ng/ml.
3)Stable disease at screening , defined by SLEDAI score of <4.
4)If on corticosteroids, the dose must be <20mg/day(Prednisone) and must be stable for preceding 4 weeks prior to entry into the study.
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method