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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05326841
Other study ID # Cholecalciferol 5000 IU
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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