Effect of Vitamin D Supplement on Disease Activity in SLE

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

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

Study Overview

• Status: Completed
• Conditions: Hyperparathyroidism; Vitamin D Deficiency; Hypocalcemia; Systemic Lupus Erythematosus (Disorder)
• Intervention / Treatment: Drug: vitamin D2 ( calciferol ); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Rajavithi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rajavithi Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 3, 2025
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Hyperparathyroidism; Hypocalcemia; End Stage Renal Disease (ESRD); calcitriol; Systemic Lupus Erythematosus ( SLE )
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Water-Electrolyte Imbalance; Parathyroid Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Calcium Metabolism Disorders; Lupus Erythematosus, Systemic; Hyperparathyroidism; Vitamin D Deficiency; Hypocalcemia; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Bone Density Conservation Agents; Micronutrients; Vitamins; Vitamin D; Ergocalciferols
• Other Study ID Numbers: 64013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No