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Completed

NCT Number: NCT05326841

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

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Key information

Conditions

Lupus Erythematosus, Systemic Autoimmune Diseases Cholecalciferol Supplementation Connective Tissue Diseases Disease Activity Immune System Diseases Quality of Life Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Rscm Divisi Alergi Imunologi

Jakarta Pusat, Dki Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D3

Drug

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

Other names: Cholecalciferol

Primary outcomes

  1. level of disease activity of participants at 12 weeks

    Time frame: 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.

  2. Level of quality of life of participants at 12 weeks

    Time frame: 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

Secondary outcomes

  1. the level vitamin D of participants at 12 weeks

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Dr Cipto Mangunkusumo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 14, 2022
Registry last updated
Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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