Systemic Lupus Erythematosus (SLE)NCT07071233
Efficacy of Vitamin C Supplementation on Serum TNF-α Levels and Disease Activity in SLE Patients
A study testing Vitamin C in people with Systemic Lupus Erythematosus (SLE), run by Universitas Sriwijaya at 1 site in Indonesia.
Trial summary
The study aimed to evaluate the efficacy of vitamin C supplementation compared to placebo towards TNF-α levels and disease activity with the MEX-SLEDAI score in Systemic Lupus Erythematosus (SLE) patients. The current study was designed as a single-center double-blind randomized controlled clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- What is being tested?
- Vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2024to 30 Nov 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients diagnosed with systemic lupus erythematosus with mild-moderate disease activity who are treated at the Allergy-Immunology Department of RSMH.
- Patients aged over 18 years.
- Willing to participate in the study by signing an informed consent form.
Who cannot join
- Pregnant or breastfeeding.
- Patients with other immune disorders such as HIV, Rheumatoid Arthritis, Pulmonary Tuberculosis, chronic liver disease, and malignancies.
- Patients currently taking supplements containing vitamin C for more than 1 week.
- Patients with a diagnosis of SLE with severe disease activity or those who have reached remission.
- Patients who are hospitalized due to SLE.
- Patients with comorbid conditions such as hemochromatosis and gastritis.
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- Drop-out Criteria
- Patients who discontinue vitamin C for more than 3 weeks.
- Death.
- Development of serious drug side effects, requiring discontinuation of the medication.
- Patients who are readmitted or experience symptom deterioration during the intervention period.
- Loss to follow-up.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Mohammad Hoesin General Hospital
Palembang, South Sumatera, 30126
About this study
Official title: Efficacy of Vitamin C Supplementation on Serum TNF-α Levels and Disease Activity in Systemic Lupus Erythematosus Patients
The study aimed to evaluate the efficacy of vitamin C supplementation compared to placebo towards TNF-α levels and disease activity with the MEX-SLEDAI score in Systemic Lupus Erythematosus (SLE) patients. The current study was designed as a single-center double-blind randomized controlled clinical trial. The participants were voluntarily recruited ≥ 18 years old SLE patients, with mild to moderate disease activity and did not consumed vitamin C 1 week prior to the trial study. Participants were randomized into two groups receiving vitamin C supplementation, or placebo. TNF-α levels and MEX-SLEDAI score were evaluated at the beginning and at the end of the 8 week trial for analysis.
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Being tested
- Vitamin C, Placebo
- Keywords
- systemic lupus erythematosus, SLE, vitamin c, TNF-alpha, Mex-SLEDAI, disease activity
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDietary supplement
The patients received vitamin C supplementation
PlaceboDietary supplement
Patients received placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C | Experimental | The patients were given a tablet containing Vitamin C 500 mg twice a day Receives: Dietary Supplement: Vitamin C |
| Placebo | Placebo comparator | The patients were given a placebo capsule with a similar color, shape, size and taste twice a day Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MEX-SLEDAI score
To determine the effectiveness of adding vitamin C compared to placebo towards disease activity in SLE patients, measured with MEX-SLEDAI score
Measured: From enrollment to the end of the treatment at 8 weeks
TNF-α
To determine the effectiveness of adding vitamin C compared to placebo towards TNF-α levels concentration change in SLE patients.
Measured: From enrollment to the end of the treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Sep 2024
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was The study was designed as a single-center double-blind randomized controlled clinical trial. Participants were randomized into two groups receiving Vitamin C or placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sriwijaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuniza, Universitas Sriwijaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071233
- Sponsor's protocol ID
- 04.03DXVIII0608ETIK204/2024
- Status last verified
- Jul 2025
- First submitted
- 30 Jun 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kong EH, Ma SY, Jeong JY, Kim KH. Effects of L-ascorbic acid on the production of pro-inflammatory and anti-inflammatory cytokines in C57BL/6 mouse splenocytes. KMJ. 2015 Jan 20;30(1):41-9.
Islam MA, Khandker SS, Kotyla PJ, Hassan R. Immunomodulatory Effects of Diet and Nutrients in Systemic Lupus Erythematosus (SLE): A Systematic Review. Front Immunol. 2020 Jul 22;11:1477. doi: 10.3389/fimmu.2020.01477. eCollection 2020.
PubMed 32793202
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Vitamin C Supplementation on Serum TNF-α Levels and Disease Activity in Systemic Lupus Erythematosus Patients
- ClinicalTrials.gov ID
- NCT07071233
- Acronym / sponsor ID
- 04.03DXVIII0608ETIK204/2024
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Keywords
- systemic lupus erythematosus, SLE, vitamin c, TNF-alpha, Mex-SLEDAI, disease activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Universitas SriwijayaUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 17 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.
The study aimed to evaluate the efficacy of vitamin C supplementation compared to placebo towards TNF-α levels and disease activity with the MEX-SLEDAI score in Systemic Lupus Erythematosus (SLE) patients. The current study was designed as a single-center double-blind randomized controlled clinical trial. The participants were voluntarily recruited ≥ 18 years old SLE patients, with mild to moderate disease activity and did not consumed vitamin C 1 week prior to the trial study. Participants were randomized into two groups receiving vitamin C supplementation, or placebo. TNF-α levels and MEX-SLEDAI score were evaluated at the beginning and at the end of the 8 week trial for analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The study was The study was designed as a single-center double-blind randomized controlled clinical trial. Participants were randomized into two groups receiving Vitamin C or placebo
| Arm | Type | Receives |
|---|---|---|
| Vitamin C | Experimental | Dietary Supplement: Vitamin CThe patients were given a tablet containing Vitamin C 500 mg twice a day |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe patients were given a placebo capsule with a similar color, shape, size and taste twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients diagnosed with systemic lupus erythematosus with mild-moderate disease activity who are treated at the Allergy-Immunology Department of RSMH.
- Patients aged over 18 years.
- Willing to participate in the study by signing an informed consent form.
Key exclusion criteria (12 listed)
- Pregnant or breastfeeding.
- Patients with other immune disorders such as HIV, Rheumatoid Arthritis, Pulmonary Tuberculosis, chronic liver disease, and malignancies.
- Patients currently taking supplements containing vitamin C for more than 1 week.
- Patients with a diagnosis of SLE with severe disease activity or those who have reached remission.
- Patients who are hospitalized due to SLE.
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 |
|---|---|---|
| Vitamin CThe patients received vitamin C supplementation | Dietary supplement | Vitamin C |
| PlaceboPatients received placebo capsules | Dietary supplement | Placebo |
Primary outcome
MEX-SLEDAI score
Time frame: From enrollment to the end of the treatment at 8 weeks
To determine the effectiveness of adding vitamin C compared to placebo towards disease activity in SLE patients, measured with MEX-SLEDAI score
TNF-α
Time frame: From enrollment to the end of the treatment at 8 weeks
To determine the effectiveness of adding vitamin C compared to placebo towards TNF-α levels concentration change in SLE patients.
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 17 Jul 2025.
- BackgroundKong EH, Ma SY, Jeong JY, Kim KH. Effects of L-ascorbic acid on the production of pro-inflammatory and anti-inflammatory cytokines in C57BL/6 mouse splenocytes. KMJ. 2015 Jan 20;30(1):41-9.
- Background: PubMed 32793202Islam MA, Khandker SS, Kotyla PJ, Hassan R. Immunomodulatory Effects of Diet and Nutrients in Systemic Lupus Erythematosus (SLE): A Systematic Review. Front Immunol. 2020 Jul 22;11:1477. doi: 10.3389/fimmu.2020.01477. eCollection 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C in people with Systemic Lupus Erythematosus (SLE), run by Universitas Sriwijaya 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 12 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 17 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. Some participants in this study may receive a placebo. 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?
MEX-SLEDAI score (time frame: From enrollment to the end of the treatment at 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07071233, which also lists 2 linked publications.
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 17 Jul 2025.