Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus Patients .

Sponsor

Dr Cipto Mangunkusumo General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05326841

Collaborator

(none)

Enrollment

Location

Arms

3.3

Actual Duration (Months)

18.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Increase in the prevalence and survival rates has led to the assessment of disease activity and quality of life of SLE patients as targets in treatment. Cholecalciferol supplementation was considered as having a role in reducing disease activity and improving quality of life.This research was a double blind, randomized, controlled trial was conducted on female outpatients aged 18-60 years with SLE, consecutively recruited from September to December 2021 at Cipto Mangunkusumo Hospital. Sixty subjects who met the research criteria were randomized and equally assigned into the cholecalciferol and placebo groups. The study outcomes were measured at baseline and after 12 weeks of intervention. we measured he level of vitamin D before and after intervention, the disease activity by MEX-SLEDAI score and the quality of life by Lupus QoL

Condition or Disease	Intervention/Treatment	Phase
Lupus Erythematosus, Systemic Cholecalciferol Supplementation Disease Activity Quality of Life	Drug: Vitamin D3	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

There are two groups : cholecalciferol group( intervention group) which get cholecalciferol 5000 iu/day for 12 weeks and saccharum lactis group ( placebo group) which get saccharum lactis for 12 weeksThere are two groups : cholecalciferol group( intervention group) which get cholecalciferol 5000 iu/day for 12 weeks and saccharum lactis group ( placebo group) which get saccharum lactis for 12 weeks

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

This study is a double blinded randomized controlled trial. Subjects were allocated in each treatment arm using permuted block randomization, with a block size of four and concealed code lists. Investigators, doctors, and subjects were blinded to treatment allocation (double blind).

Primary Purpose:

Treatment

Official Title:

Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus Patients

Actual Study Start Date :

Oct 3, 2021

Actual Primary Completion Date :

Jan 11, 2022

Actual Study Completion Date :

Jan 11, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cholecalciferol group Participants in this arm take a vitamin D3 dose 5000 international units (IU) daily by mouth for a duration of 12 weeks	Drug: Vitamin D3 cholecalciferol tablet, the dose is 5000 international unit /day for 12 weeks Other Names: Cholecalciferol
Placebo Comparator: placebo group Participants in this arm take a vitamin D3 placebo daily by mouth for a duration of 12 weeks	Drug: Vitamin D3 cholecalciferol tablet, the dose is 5000 international unit /day for 12 weeks Other Names: Cholecalciferol

Arm

Intervention/Treatment

Experimental: Cholecalciferol group

Participants in this arm take a vitamin D3 dose 5000 international units (IU) daily by mouth for a duration of 12 weeks

Drug: Vitamin D3

cholecalciferol tablet, the dose is 5000 international unit /day for 12 weeks

Other Names:

Cholecalciferol

Placebo Comparator: placebo group

Participants in this arm take a vitamin D3 placebo daily by mouth for a duration of 12 weeks

Drug: Vitamin D3

cholecalciferol tablet, the dose is 5000 international unit /day for 12 weeks

Other Names:

Cholecalciferol

Outcome Measures

Primary Outcome Measures

level of disease activity of participants at 12 weeks [level of vitamin d was measured at 12 weeks after the intervention]
level of disease activity from the participants at 12 weeks as respons from taking vitamin D and placebo by using Mex-sledai with score from 0 until 34. no activity or remission is 0-1, mild 2-5, moderate 6-9, severe 10-13, very severe more than and equally of 14.
Level of quality of life of participants at 12 weeks [level of quality of life was measured at 12 weeks after intervention]
Level of lupus quality of life from the participants at 12 weeks as respsons from taking vitamin d and placebo by using Lupus QoL with score minimal 0, maximal 100. better quality of life > 75

Secondary Outcome Measures

the level vitamin D of participants at 12 weeks [Level of vitamin D was measured at 12 weeks after intervention]
the level of vitamin D from participants at 12 weeks as respons from taking vitamin D3 and placebo

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women subjects aged 18-60 years old with hypovitaminosis D

Exclusion Criteria:

declining consent to participate, late stage chronic kidney disease (staged 4-5), decompensated liver cirrhosis, consumption of glucocorticoids (equivalent to prednisone 20 mg/day) in the past 30 days, pregnant or lactating, patients with acute infection, hypercalcemic patients, anticonvulsant consumption.