Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Level of quality of life of participants at 12 weeks
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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).
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women subjects aged 18-60 years old with hypovitaminosis D
排除标准
- •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.
研究组 & 干预措施
Cholecalciferol group
Participants in this arm take a vitamin D3 dose 5000 international units (IU) daily by mouth for a duration of 12 weeks
干预措施: Vitamin D3 (Drug)
placebo group
Participants in this arm take a vitamin D3 placebo daily by mouth for a duration of 12 weeks
干预措施: Vitamin D3 (Drug)
结局指标
主要结局
Level of quality of life of participants at 12 weeks
时间窗: 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
level of disease activity of participants at 12 weeks
时间窗: 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.
次要结局
- the level vitamin D of participants at 12 weeks(Level of vitamin D was measured at 12 weeks after intervention)
研究者
Fiblia
student
Dr Cipto Mangunkusumo General Hospital