Effect of Vitamin D Supplement on Disease Activity in SLE

Study Overview
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Brief Summary
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To study the effect of vitamin D supplementation on disease activity of SLE ( SLEDAI-2K ) and IL-6 level

Official Title
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The Effect of Vitamin D Supplementation on Disease Activity of Systemic Lupus Erythematosus Patients: A Randomized Clinical Trial in Rajavithi Hospital

Conditions
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Vitamin D Deficiency, Hypocalcemia, Hyperparathyroidism, Systemic Lupus Erythematosus (Disorder)

Intervention / Treatment
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* Drug: vitamin D2 ( calciferol )
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 year-old SLE classified by revised ACR criteria, SLICC 2012 criteria SLE patients who have mild to moderate disease activity ( clinical SLEDAI-2K 3-10 ) and has vitamin D level < 40 ng/ml currently treated with stable dose of 1 or more of the following background medication : NSAIDs, anti-malarial, MMF, Azathioprine, methotrexate, cyclosporin for at least 1 month, corticosteroid </= 20 mg/d of prednisolone or equivalent dose for at least 2 weeks received calciferol 20,000 IU/wk (1 cap) at least 12 weeks Exclusion Criteria: patients with chronic liver disease, CKD stage 3, bed ridden, malignancy patients who received drug that interfere with vitamin D metabolism poor drug compliance overlap with other connective tissue disease or a diagnosis of MCTD hx of vitamin D allergy hx on MTV or other supplementation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vitamin D supplementation<br>add on vitamin D2 ( calciferol ) 40,000 IU/wk for 12 weeks | Drug: vitamin D2 ( calciferol )<br>* add on vitamin D2( calciferol ) 40,000 IU/wk ( 2 cap) for 12 weeks<br>|
| Placebo Comparator: placebo<br>add on placebo for 12 weeks | Drug: Placebo<br>* add on placebo ( 2 cap ) for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the effect of vitamin D supplementation on SLE disease activity | Study the SLE disease activity by SLEDAI-2K in relation with vitamin D levels | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the effect of vitamin D supplementation on IL-6 level | monitor serum vitamin D before and after intervention | 12 weeks | 
| To determine whether IL-6 can early detection in SLE disease flare | monitor serum IL-6 before and after intervention compare with SLE disease activity index ( SLEDAI-2K ) | 12 weeks | 
| To determine adverse reaction of high dose vitamin D | monitor adverse reaction of vitamin D after intervention | 12 weeks | 
| To study the effect of vitamin D supplementation on anti-dsDNA titer | monitor serum anti-dsDNA titer before and after intervention | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypocalcemia, Hyperparathyroidism, End Stage Renal Disease (ESRD), calcitriol, Systemic Lupus Erythematosus ( SLE )