Clinical trial NCT05260255: Effect of Vitamin D Supplement on Disease Activity in SLE
Official title: The Effect of Vitamin D Supplementation on Disease Activity of Systemic Lupus Erythematosus Patients: a Randomized Clinical Trial in Rajavithi Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Hypocalcemia
Hyperparathyroidism
Systemic Lupus Erythematosus (Disorder)
Keywords: Hypocalcemia
Hyperparathyroidism
End Stage Renal Disease (ESRD)
calcitriol
Systemic Lupus Erythematosus ( SLE )
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2022-03-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: To examine the effect of vitamin D supplementation on SLE disease activity
timeFrame: 12 weeks
Secondary outcomes:
measure: To examine the effect of vitamin D supplementation on IL-6 level
timeFrame: 12 weeks
measure: To determine whether IL-6 can early detection in SLE disease flare
timeFrame: 12 weeks
measure: To determine adverse reaction of high dose vitamin D
timeFrame: 12 weeks
measure: To study the effect of vitamin D supplementation on anti-dsDNA titer
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
References:
citation: Ding J, Su S, You T, Xia T, Lin X, Chen Z, Zhang L. Serum interleukin-6 level is correlated with the disease activity of systemic lupus erythematosus: a meta-analysis. Clinics (Sao Paulo). 2020 Oct 19;75:e1801. doi: 10.6061/clinics/2020/e1801. eCollection 2020.
citation: Hassanalilou T, Khalili L, Ghavamzadeh S, Shokri A, Payahoo L, Bishak YK. Role of vitamin D deficiency in systemic lupus erythematosus incidence and aggravation. Auto Immun Highlights. 2017 Dec 26;9(1):1. doi: 10.1007/s13317-017-0101-x.
citation: Aranow C, Kamen DL, Dall'Era M, Massarotti EM, Mackay MC, Koumpouras F, Coca A, Chatham WW, Clowse ME, Criscione-Schreiber LG, Callahan S, Goldmuntz EA, Keyes-Elstein L, Oswald M, Gregersen PK, Diamond B. Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Vitamin D3 on the Interferon Signature in Patients With Systemic Lupus Erythematosus. Arthritis Rheumatol. 2015 Jul;67(7):1848-57. doi: 10.1002/art.39108.