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

Dr Cipto Mangunkusumo General Hospital

Status and phase: Completed; Phase 3

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

Treatments: Drug: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT05326841

Cholecalciferol 5000 IU

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Cholecalciferol group

Experimental group

Description:

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

Treatment:

Drug: Vitamin D3

placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: Vitamin D3