Effect of Vitamin D Supplement on Disease Activity in SLE

Not Applicable

Completed

• Conditions: Hypocalcemia; Systemic Lupus Erythematosus (Disorder); Vitamin D Deficiency; Hyperparathyroidism
• Interventions: Drug: vitamin D2 ( calciferol ); Drug: Placebo

• Registration Number: NCT05260255
• Lead Sponsor: Rajavithi Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-12
• Study Start: 2021-06-15
• Study First Submitted QC: 2022-02-24
• Study First Posted: 2022-03-02
• Primary Completion: 2022-05-01
• Study Completion: 2022-12-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vitamin D supplementation	vitamin D2 ( calciferol )	add on vitamin D2 ( calciferol ) 40,000 IU/wk for 12 weeks
placebo	Placebo	add on placebo for 12 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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 examine the effect of vitamin D supplementation on IL-6 level	12 weeks	monitor serum vitamin D before and after intervention

Trial Locations

Locations (1)

Rajavithi Hospital; 🇹🇭 Bangkok, Thailand