Hyperparathyroidism, Hypocalcemia, Systemic Lupus Erythematosus (Disorder), Vitamin D Deficiency
Conditions
Keywords
Hypocalcemia, Hyperparathyroidism, End Stage Renal Disease (ESRD), calcitriol, Systemic Lupus Erythematosus ( SLE )
Brief summary
To study the effect of vitamin D supplementation on disease activity of SLE ( SLEDAI-2K ) and IL-6 level
Interventions
DRUGvitamin D2 ( calciferol )
add on vitamin D2( calciferol ) 40,000 IU/wk ( 2 cap) for 12 weeks
DRUGPlacebo
add on placebo ( 2 cap ) for 12 weeks
Sponsors
Department of Medical Services Ministry of Public Health of Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To examine the effect of vitamin D supplementation on SLE disease activity | 12 weeks | Study the SLE disease activity by SLEDAI-2K in relation with vitamin D levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To examine the effect of vitamin D supplementation on IL-6 level | 12 weeks | monitor serum vitamin D before and after intervention |
| To determine whether IL-6 can early detection in SLE disease flare | 12 weeks | monitor serum IL-6 before and after intervention compare with SLE disease activity index ( SLEDAI-2K ) |
| To determine adverse reaction of high dose vitamin D | 12 weeks | monitor adverse reaction of vitamin D after intervention |
| To study the effect of vitamin D supplementation on anti-dsDNA titer | 12 weeks | monitor serum anti-dsDNA titer before and after intervention |
Countries
Thailand
Outcome results
None listed