Effect of Vitamin D Supplement on Disease Activity in SLE

N/ACompletedNCT05260255

Department of Medical Services Ministry of Public Health of Thailand100 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Vitamin D Deficiency Hypocalcemia Hyperparathyroidism Systemic Lupus Erythematosus (Disorder)

Interventions

vitamin D2 ( calciferol )DRUG

add on vitamin D2( calciferol ) 40,000 IU/wk ( 2 cap) for 12 weeks

PlaceboDRUG

add on placebo ( 2 cap ) for 12 weeks

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Rajavithi Hospital

Bangkok, Bangkok, Thailand

Outcomes

Primary Outcomes

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

Time frame: 12 weeks

Secondary Outcomes

To examine the effect of vitamin D supplementation on IL-6 level

monitor serum vitamin D before and after intervention

Time frame: 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 )

Time frame: 12 weeks

To determine adverse reaction of high dose vitamin D

monitor adverse reaction of vitamin D after intervention

Time frame: 12 weeks

To study the effect of vitamin D supplementation on anti-dsDNA titer

monitor serum anti-dsDNA titer before and after intervention

Time frame: 12 weeks

Data from ClinicalTrials.gov

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