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

Phase 3

Completed

• Conditions: Lupus Erythematosus, Systemic; Cholecalciferol Supplementation; Disease Activity; Quality of Life
• Interventions: Drug: Vitamin D3

• Registration Number: NCT05326841
• Lead Sponsor: Dr Cipto Mangunkusumo General Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-03
• Primary Completion: 2022-01-11
• Study Completion: 2022-01-11
• Study First Submitted: 2022-03-23
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-06
• Last Update Submitted: 2022-04-06
• Study First Posted: 2022-04-14
• Last Update Posted: 2022-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cholecalciferol group	Vitamin D3	Participants in this arm take a vitamin D3 dose 5000 international units (IU) daily by mouth for a duration of 12 weeks
placebo group	Vitamin D3	Participants in this arm take a vitamin D3 placebo daily by mouth for a duration of 12 weeks

Primary Outcome Measures

Name	Time	Method
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
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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Rscm Divisi Alergi Imunologi; 🇮🇩 Jakarta Pusat, Dki Jakarta, Indonesia