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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05326841
• Other study ID #: Cholecalciferol 5000 IU
• Status: Completed
• Phase: Phase 3
• Start date: October 3, 2021
• Est. completion date: January 11, 2022

Study information

• Verified date: April 2022
• Source: Dr Cipto Mangunkusumo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 11, 2022
• Est. primary completion date: January 11, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Quality of Life

Intervention

Drug:
• Vitamin D3
cholecalciferol tablet, the dose is 5000 international unit /day for 12 weeks

Locations

Country	Name	City	State
Indonesia	Rscm Divisi Alergi Imunologi	Jakarta Pusat	Dki Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Dr Cipto Mangunkusumo General Hospital

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of disease activity of participants at 12 weeks	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 vitamin d was measured at 12 weeks after the intervention
Primary	Level of quality of life of participants at 12 weeks	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 quality of life was measured at 12 weeks after intervention
Secondary	the level vitamin D of participants at 12 weeks	the level of vitamin D from participants at 12 weeks as respons from taking vitamin D3 and placebo	Level of vitamin D was measured at 12 weeks after intervention