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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-03

Study Completion Date

2022-01-11

Brief Summary

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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

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Detailed Description

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Conditions

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Lupus Erythematosus, Systemic Cholecalciferol Supplementation Disease Activity Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 weeks

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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).

Study Groups

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Cholecalciferol group

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

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DRUG

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

placebo group

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

Group Type PLACEBO_COMPARATOR

Vitamin D3

Intervention Type DRUG

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

Interventions

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Vitamin D3

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

Intervention Type DRUG

Other Intervention Names

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Cholecalciferol

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No