Cholecalciferol Supplementation, Disease Activity, Lupus Erythematosus, Systemic, Quality of Life
Conditions
Keywords
lupus erythematosus systemic, cholecalciferol supplementation, Mex-SLEDAI score, Lupus QoL
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
Interventions
DRUGVitamin D3
cholecalciferol tablet, the dose is 5000 international unit /day for 12 weeks
Sponsors
Dr Cipto Mangunkusumo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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).
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 weeks
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Indonesia
Outcome results
None listed