Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus Patients .
Primary Purpose
Lupus Erythematosus, Systemic, Cholecalciferol Supplementation, Disease Activity
Status
Completed
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
Vitamin D3
Sponsored by
About this trial
This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring lupus erythematosus systemic, cholecalciferol supplementation, Mex-SLEDAI score, Lupus QoL
Eligibility Criteria
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.
Sites / Locations
- Rscm Divisi Alergi Imunologi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Cholecalciferol group
placebo group
Arm Description
Participants in this arm take a vitamin D3 dose 5000 international units (IU) daily by mouth for a duration of 12 weeks
Participants in this arm take a vitamin D3 placebo daily by mouth for a duration of 12 weeks
Outcomes
Primary Outcome Measures
level of disease activity of participants at 12 weeks
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 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
the level of vitamin D from participants at 12 weeks as respons from taking vitamin D3 and placebo
Full Information
NCT ID
NCT05326841
First Posted
March 23, 2022
Last Updated
April 6, 2022
Sponsor
Dr Cipto Mangunkusumo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05326841
Brief Title
Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus Patients .
Official Title
Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 3, 2021 (Actual)
Primary Completion Date
January 11, 2022 (Actual)
Study Completion Date
January 11, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr Cipto Mangunkusumo General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Erythematosus, Systemic, Cholecalciferol Supplementation, Disease Activity, Quality of Life
Keywords
lupus erythematosus systemic, cholecalciferol supplementation, Mex-SLEDAI score, Lupus QoL
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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 weeks
Masking
ParticipantCare ProviderInvestigatorOutcomes 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).
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cholecalciferol group
Arm Type
Experimental
Arm Description
Participants in this arm take a vitamin D3 dose 5000 international units (IU) daily by mouth for a duration of 12 weeks
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
Participants in this arm take a vitamin D3 placebo daily by mouth for a duration of 12 weeks
Intervention Type
Drug
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
Cholecalciferol
Intervention Description
cholecalciferol tablet, the dose is 5000 international unit /day for 12 weeks
Primary Outcome Measure Information:
Title
level of disease activity of participants at 12 weeks
Description
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.
Time Frame
level of vitamin d was measured at 12 weeks after the intervention
Title
Level of quality of life of participants at 12 weeks
Description
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
Time Frame
level of quality of life was measured at 12 weeks after intervention
Secondary Outcome Measure Information:
Title
the level vitamin D of participants at 12 weeks
Description
the level of vitamin D from participants at 12 weeks as respons from taking vitamin D3 and placebo
Time Frame
Level of vitamin D was measured at 12 weeks after intervention
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
subjects in this research were female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Rscm Divisi Alergi Imunologi
City
Jakarta Pusat
State/Province
Dki Jakarta
ZIP/Postal Code
10430
Country
Indonesia
12. IPD Sharing Statement
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Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus Patients .
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