Effect of Vitamin D Supplement on Disease Activity in SLE

Sponsor

Rajavithi Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05260255

Collaborator

(none)

100

Enrollment

Location

Arms

17.5

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency Hypocalcemia Hyperparathyroidism Systemic Lupus Erythematosus (Disorder)	Drug: vitamin D2 ( calciferol ) Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 15, 2021

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

To examine the effect of vitamin D supplementation on IL-6 level [12 weeks]
monitor serum vitamin D 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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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