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

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

Study Overview

• Status: Completed
• Conditions: Quality of Life; Lupus Erythematosus, Systemic; Disease Activity; Cholecalciferol Supplementation
• Intervention / Treatment: Drug: Vitamin D3

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Indonesia
  • Dki Jakarta
    • Jakarta Pusat, Dki Jakarta, Indonesia, 10430
      • Rscm Divisi Alergi Imunologi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cholecalciferol group; 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; cholecalciferol tablet, the dose is 5000 international unit /day for 12 weeks; Other Names: Cholecalciferol
PLACEBO_COMPARATOR: placebo group; Participants in this arm take a vitamin D3 placebo daily by mouth for a duration of 12 weeks	Drug: Vitamin D3; cholecalciferol tablet, the dose is 5000 international unit /day for 12 weeks; Other Names: Cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Dr Cipto Mangunkusumo General Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 3, 2021
• Primary Completion (ACTUAL): January 11, 2022
• Study Completion (ACTUAL): January 11, 2022

Study Registration Dates

• First Submitted: March 23, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (ACTUAL): April 14, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: cholecalciferol supplementation; lupus erythematosus systemic; Mex-SLEDAI score; Lupus QoL
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: Cholecalciferol 5000 IU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No