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Completed

NCT Number: NCT07069348

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

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.

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Key information

Conditions

SLE

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitas Brawijaya

Malang, East Java, 65145, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children aged 7 to 18 years.
  • Diagnosed with Systemic Lupus Erythematosus (SLE) based on ACR or SLICC classification criteria.
  • Receiving care or follow-up at Dr. Saiful Anwar Hospital, Malang during the study period and willing to participate in the study and provide informed consent (from parents or guardians).

Exclusion criteria

  • Currently receiving vitamin D supplementation or medications known to influence vitamin D metabolism (e.g., anticonvulsants, glucocorticoids in high doses, etc.).
  • Diagnosed with chronic kidney disease, liver disease, or malabsorption disorders.
  • Diagnosed with other autoimmune diseases besides SLE.
  • Presence of acute infection or fever at the time of data collection.
  • Incomplete clinical or laboratory data required for analysis (e.g., missing ELISA or flow cytometry results).

Treatment and study plan

No intervention

Other

There is no treatment or intervention administered to the patients

Primary outcomes

  1. 25-hydroxyvitamin D (25(OH)D)

    Time frame: At the time of enrollment

    Correlation between serum 25(OH)D levels and SLE disease activity (SLEDAI score)

  2. Zinc serum

    Time frame: At the time of enrollment

    Correlation between Zinc serum and SLE disease activity (SLEDAI score)

  3. The Percentage of Th17 and Treg

    Time frame: At the time of enrollment

    Correlation between The Percentage of Th17 and Treg with SLE disease activity (SLEDAI score)

Sponsors and collaborators

Lead sponsor

Wisnu Barlianto

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 16, 2025
Registry last updated
Jul 18, 2025

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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