Effect of Vitamin D Supplement on Disease Activity in SLE

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05260255
• Other study ID #: 64013
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: May 2021
• Source: Rajavithi Hospital
• Contact: Thipsukhon Sathapanasiri, Medicine
• Phone: 0860977893
• Email: zalapochan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hypocalcemia
• Lupus Erythematosus, Systemic
• Vitamin D Deficiency

Intervention

Drug:
• vitamin D2 ( calciferol )
add on vitamin D2( calciferol ) 40,000 IU/wk ( 2 cap) for 12 weeks
• Placebo
add on placebo ( 2 cap ) for 12 weeks

Locations

Country	Name	City	State
Thailand	Rajavithi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

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 — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To examine the effect of vitamin D supplementation on IL-6 level	monitor serum vitamin D before and after intervention	12 weeks
Secondary	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
Secondary	To determine adverse reaction of high dose vitamin D	monitor adverse reaction of vitamin D after intervention	12 weeks
Secondary	To study the effect of vitamin D supplementation on anti-dsDNA titer	monitor serum anti-dsDNA titer before and after intervention	12 weeks