NCT05326841

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Dr Cipto Mangunkusumo General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Conditions

• Lupus Erythematosus, Systemic
• Cholecalciferol Supplementation
• Disease Activity
• Quality of Life

Interventions

Type	Name	Description
DRUG	Vitamin D3	cholecalciferol tablet, the dose is 5000 international unit /day for 12 weeks

Timeline

• Start date: 2021-10-03
• Primary completion: 2022-01-11
• Completion: 2022-01-11
• First posted: 2022-04-14
• Last updated: 2022-04-14

Locations

1 site across 1 country: Indonesia