NCT07069348

SLE Severity Linked to Vitamin D Via Treg Cells in Pediatric Patients

The Bearing Between Systemic Lupus Erythematosus Severity With Vitamin D Through Treg Cell Entanglement in Pediatric Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: Wisnu Barlianto · Academic / Other
• Sex: All
• Age: 7 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

SLE has been characterized by dysfunctional or decreased numbers of Treg cells because one of it function is to prevent autoimmunity. Vitamin D has already known to increase the number and function of Treg by enhancing their differentiation and expansion. This study aims to investigate the relationship between SLE severity in pediatric patients and vitamin D levels through modulation of Treg cells. This is a cross-sectional study of all children aged 7-18 years old who sought care for SLE at Dr. Saiful Anwar Hospital Malang between March 2024 until December 2024. 25(OH)D level was obtained by ELISA, Treg cell percentage was obtained by flow cytometry, and patient severity was measured by SLEDAI score.

Detailed description

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease that affects multiple organ systems and often begins during childhood or adolescence. Regulatory T cells (Treg) play a critical role in suppressing autoimmune responses, and several studies have shown that patients with SLE tend to have reduced numbers and/or function of Treg cells. Vitamin D has been reported to enhance Treg cell differentiation and function, suggesting a potential immunomodulatory role. This cross-sectional observational study aims to evaluate the relationship between vitamin D status and disease severity in pediatric patients with SLE by examining the role of Treg cells as a potential mediator. Pediatric patients aged 7 to 18 years who are diagnosed with SLE and receiving care at Dr. Saiful Anwar Hospital, Malang, between March and December 2024 will be included. Serum 25(OH)D levels will be measured using ELISA, and Treg cell percentages will be assessed via flow cytometry. Disease severity will be determined using the SLE Disease Activity Index (SLEDAI). Findings from this study are expected to provide insight into the immunological mechanism involving vitamin D and Treg cells in pediatric SLE and potentially guide future interventions or supplementation strategies.

Conditions

• SLE

Interventions

Type	Name	Description
OTHER	No intervention	There is no treatment or intervention administered to the patients

Timeline

• Start date: 2024-03-03
• Primary completion: 2024-12-03
• Completion: 2024-12-03
• First posted: 2025-07-16
• Last updated: 2025-07-18

Locations

1 site across 1 country: Indonesia