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

NCT05326841 | Completed Phase 3 DMC

• 1 other identifier: Cholecalciferol 5000 IU
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

lupus erythematosus systemic; cholecalciferol supplementation; Mex-SLEDAI score; Lupus QoL

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• the level vitamin D of participants at 12 weeks

  Level of vitamin D was measured at 12 weeks after intervention

Study Arms (2)

Cholecalciferol group

EXPERIMENTAL

Participants in this arm take a vitamin D3 dose 5000 international units (IU) daily by mouth for a duration of 12 weeks

Drug: Vitamin D3

placebo group

PLACEBO COMPARATOR

Participants in this arm take a vitamin D3 placebo daily by mouth for a duration of 12 weeks

Drug: Vitamin D3

Interventions

Vitamin D3 DRUG

cholecalciferol tablet, the dose is 5000 international unit /day for 12 weeks

Also known as: Cholecalciferol

Cholecalciferol group; placebo group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: subjects in this research were female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women subjects aged 18-60 years old with hypovitaminosis D

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr Cipto Mangunkusumo General Hospital: lead

Study Sites (1)

Rscm Divisi Alergi Imunologi

Jakarta Pusat, Dki Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: student

Model Details: There are two groups : cholecalciferol group( intervention group) which get cholecalciferol 5000 iu/day for 12 weeks and saccharum lactis group ( placebo group) which get saccharum lactis for 12 weeks

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 14, 2022
• Study Start: October 3, 2021
• Primary Completion: January 11, 2022
• Study Completion: January 11, 2022
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

ID (1)