Effect of Vitamin D Supplement on Disease Activity in SLE

NCT05260255 | Completed DMC

• 1 other identifier: 64013
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vitamin D Deficiency; Hypocalcemia; Hyperparathyroidism; Systemic Lupus Erythematosus (Disorder)

Keywords

Hypocalcemia; Hyperparathyroidism; End Stage Renal Disease (ESRD); calcitriol; Systemic Lupus Erythematosus ( SLE )

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  12 weeks

• To determine whether IL-6 can early detection in SLE disease flare

  12 weeks

• To determine adverse reaction of high dose vitamin D

  12 weeks

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

  12 weeks

Study Arms (2)

vitamin D supplementation

EXPERIMENTAL

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

Drug: vitamin D2 ( calciferol )

placebo

PLACEBO COMPARATOR

add on placebo for 12 weeks

Drug: Placebo

Interventions

vitamin D2 ( calciferol ) DRUG

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

vitamin D supplementation

Placebo DRUG

add on placebo ( 2 cap ) for 12 weeks

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi Hospital

Bangkok, Bangkok, 10400, Thailand

Location

Related Publications (3)

• 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.

  PMID: 33084768 BACKGROUND

• 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.

  PMID: 29280010 BACKGROUND

• 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.

  PMID: 25777546 BACKGROUND

MeSH Terms

Conditions

Vitamin D Deficiency; Hypocalcemia; Hyperparathyroidism; Lupus Erythematosus, Systemic; Kidney Failure, Chronic

Interventions

Ergocalciferols; Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Water-Electrolyte Imbalance; Parathyroid Diseases; Endocrine System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: March 2, 2022
• Study Start: June 15, 2021
• Primary Completion: May 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 6, 2025

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share

Locations

TH (1)