NCT07069348Completed
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
Source: ClinicalTrials.gov · Last updated 18 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 32 (actual)
- First submitted
- 7 Jul 2025
- Start date
- 3 Mar 2024
- Primary completion date
- 3 Dec 2024
- Lead sponsor
- Wisnu Barlianto
- Diseases
- Lupus (SLE)
- NCT number
- NCT07069348
What you commit to
- Study type: Observational
- Participants enrolled: 32
- From 3 Mar 2024 to the primary completion date, 3 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving vitamin D supplementation or medications known to influence vitamin D metabolism (e.g., anticonvulsants, glucocorticoids in high doses, etc.).
Other illness
- 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.
Lab values
- Incomplete clinical or laboratory data required for analysis (e.g., missing ELISA or flow cytometry results).
Who the study is looking for
- 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).
Age in the registry: 7 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitas Brawijaya Coordinator of this site? Confirm its status | Malang | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.