Back to results

Effect of Vitamin D Supplement on Disease Activity in SLE

Primary Purpose

Vitamin D Deficiency, Hypocalcemia, Hyperparathyroidism

Status

Unknown status

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

vitamin D2 ( calciferol )

Placebo

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Hypocalcemia, Hyperparathyroidism, End Stage Renal Disease (ESRD), calcitriol, Systemic Lupus Erythematosus ( SLE )

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Rajavithi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

vitamin D supplementation

placebo

Arm Description

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

add on placebo for 12 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

monitor serum vitamin D before and after intervention

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 )

To determine adverse reaction of high dose vitamin D

monitor adverse reaction of vitamin D after intervention

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

monitor serum anti-dsDNA titer before and after intervention

Full Information

NCT ID

NCT05260255

First Posted

May 12, 2021

Last Updated

February 24, 2022

Sponsor

Rajavithi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05260255

Brief Title

Effect of Vitamin D Supplement on Disease Activity in SLE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 15, 2021 (Actual)

Primary Completion Date

May 1, 2022 (Anticipated)

Study Completion Date

December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rajavithi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

vitamin D supplementation

Arm Type

Experimental

Arm Description

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

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

add on placebo for 12 weeks

Intervention Type

Drug

Intervention Name(s)

vitamin D2 ( calciferol )

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

add on placebo ( 2 cap ) for 12 weeks

Primary Outcome Measure Information:

Title

To examine the effect of vitamin D supplementation on SLE disease activity

Description

Study the SLE disease activity by SLEDAI-2K in relation with vitamin D levels

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

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

Description

monitor serum vitamin D before and after intervention

Time Frame

12 weeks

Title

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

Description

monitor serum IL-6 before and after intervention compare with SLE disease activity index ( SLEDAI-2K )

Time Frame

12 weeks

Title

To determine adverse reaction of high dose vitamin D

Description

monitor adverse reaction of vitamin D after intervention

Time Frame

12 weeks

Title

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

Description

monitor serum anti-dsDNA titer before and after intervention

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Thipsukhon Sathapanasiri, Medicine

Phone

0860977893

zalapochan@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Kittiwan Sumethkul, Rheumato

Phone

0896658160

ckittiwan@hotmail.com

Facility Information:

Facility Name

Rajavithi Hospital

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thipsukhon Sathapanasiri, Medicine

Phone

086097789

zalapochan@gmail.com

First Name & Middle Initial & Last Name & Degree

Kittiwan Sumethkul, rheumato

Phone

0896658160

ckittiwan@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

33084768

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 2020.

Results Reference

result

PubMed Identifier

29280010

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.

Results Reference

result

PubMed Identifier

25777546

Citation

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.

Results Reference

result

Learn more about this trial

Effect of Vitamin D Supplement on Disease Activity in SLE

We'll reach out to this number within 24 hrs