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NCT05326841
Effect of Cholecalciferol Supplementation on Disease Activity and Quality of Life of Systemic Lupus Erythematosus Patients .
Phase 3 trial testing Vitamin D3 in Lupus Erythematosus, Systemic in 60 participants. Completed in 11 January 2022.
11 January 2022
Quick facts
| Lead sponsor | Dr Cipto Mangunkusumo General Hospital |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 3 October 2021 |
| Primary completion | 11 January 2022 |
| Estimated completion | 11 January 2022 |
| Sites | 1 location across Indonesia |
Drugs / interventions tested
- Vitamin D3 (cholecalciferol) — full drug profile →
Conditions studied
- Lupus Erythematosus, Systemic — all drugs for Lupus Erythematosus, Systemic →
- Cholecalciferol Supplementation — all drugs for Cholecalciferol Supplementation →
- Disease Activity — all drugs for Disease Activity →
- Quality of Life — all drugs for Quality of Life →
Sponsor
Dr Cipto Mangunkusumo General Hospital
Who can join
Adults 18 to 60, female only, with Lupus Erythematosus, Systemic or Cholecalciferol Supplementation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Modulation of the immunity and inflammation by autophagy.
Gan T, Qu S, Zhang H, Zhou XJ. · · 2023 · cited 27× · PMID 37405276 · DOI 10.1002/mco2.311
Verify or expand the search:
- PubMed search for NCT05326841
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for Lupus Erythematosus, Systemic
Currently open trials in the same condition.
- NCT07424261 — NIS to Examine Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care · recruiting
- NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
- NCT07330245 — Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab. · recruiting
- NCT07015983 — A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite I · Phase 2 · recruiting
- NCT06881290 — Vunakizumab for the Treatment of Mild to Moderate Systemic Lupus Erythematosus · Phase 1 · recruiting
Other Dr Cipto Mangunkusumo General Hospital trials
Trials by the same sponsor.
- NCT07074548 — Effect of Hydroxytyrosol on NLR, MLR, and SOD in Hypertensive Pregnant Women · NA · completed
- NCT07141940 — Indonesian-Language Application-Based Guided Imagery Therapy for Insomnia and Glycemic Control in Diabetic Patients · NA · completed
- NCT07422116 — Non-Inferiority Test of Mixsafe® Compared to Neopuff® in Providing Respiratory Support to Neonates · NA · completed
- NCT06929793 — Multiple Micronutrients Supplementation on Angiogenesis and Vasculogenesis Factors, and Fetal Biometry · NA · active not recruiting
- NCT07149272 — Lactate Kinetics Analysis Related to Low-Intensity Resistance Exercise · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05326841 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dr Cipto Mangunkusumo General Hospital
- Last refreshed: 14 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05326841.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing