SLENCT07069348
SLE Severity Linked to Vitamin D Via Treg Cells in Pediatric Patients
An observational study of SLE, run by Wisnu Barlianto at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- SLE
- How many people
- 32 participants
- Where
- 1 siteIndonesia
- Study dates
- 3 Mar 2024to 3 Dec 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Bearing Between Systemic Lupus Erythematosus Severity With Vitamin D Through Treg Cell Entanglement 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.
Read the 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
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no treatment or intervention administered to the patients
| Study group | Role | What they receive |
|---|---|---|
| SLE ped | SLE pediatric patients without intervention Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
25-hydroxyvitamin D (25(OH)D)
Correlation between serum 25(OH)D levels and SLE disease activity (SLEDAI score)
Measured: At the time of enrollment
Zinc serum
Correlation between Zinc serum and SLE disease activity (SLEDAI score)
Measured: 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)
Measured: At the time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start3 Mar 2024
- Primary completion3 Dec 2024
- Study completion3 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SLEStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Wisnu Barlianto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wisnu Barlianto, University of Brawijaya
- Investigators
- Wisnu Barlianto, Prof., Study chair, Faculty of Medicine Universitas Brawijaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069348
- Sponsor's protocol ID
- SLE VIT D Treg
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will maintain the confidentiality of our patients' data
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bearing Between Systemic Lupus Erythematosus Severity With Vitamin D Through Treg Cell Entanglement in Pediatric Patients
- ClinicalTrials.gov ID
- NCT07069348
- Acronym / sponsor ID
- SLE VIT D Treg
- Conditions
- SLE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Wisnu BarliantoUniversity, hospital or other
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- 3 Dec 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SLE ped | – | Other: No interventionSLE pediatric patients without intervention |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThere is no treatment or intervention administered to the patients | Other | SLE ped |
Primary outcome
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)
Zinc serum
Time frame: At the time of enrollment
Correlation between Zinc serum and SLE disease activity (SLEDAI score)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No. We will maintain the confidentiality of our patients' data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wisnu Barlianto, Prof. study chair
Faculty of Medicine Universitas Brawijaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SLE, run by Wisnu Barlianto at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
25-hydroxyvitamin D (25(OH)D) (time frame: At the time of enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.