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

NCT07069348 | Completed

• 1 other identifier: SLE VIT D Treg
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SLE

Outcome Measures

Primary Outcomes (3)

• 25-hydroxyvitamin D (25(OH)D)

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

  At the time of enrollment

• Zinc serum

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

  At the time of enrollment

• The Percentage of Th17 and Treg

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

  At the time of enrollment

Study Arms (1)

SLE ped

SLE pediatric patients without intervention

Other: No intervention

Interventions

No intervention OTHER

There is no treatment or intervention administered to the patients

SLE ped

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients aged 7 to 18 years who have been diagnosed with Systemic Lupus Erythematosus (SLE) and are receiving care at Dr. Saiful Anwar Hospital, Malang, Indonesia. Participants are recruited between March and December 2024 as part of a cross-sectional observational study evaluating vitamin D levels, Treg and Th17 cell percentage, zinc serum, and disease severity.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Wisnu Barlianto: lead

Study Sites (1)

Universitas Brawijaya

Malang, East Java, 65145, Indonesia

Location

Study Officials

• Wisnu Barlianto, Prof.

  Faculty of Medicine Universitas Brawijaya

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. dr. WISNU BARLIANTO, M.Si.Med., Sp.A(K).

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 16, 2025
• Study Start: March 3, 2024
• Primary Completion: December 3, 2024
• Study Completion: December 3, 2024
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)