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

• Status: Completed
• Trial end date: 2022-01-11
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dr Cipto Mangunkusumo General Hospital
• Treatments: Cholecalciferol; Vitamin D

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.