Efficacy of Vitamin C Supplementation on Serum TNF-α Levels and Disease Activity in SLE Patients

Not Applicable

Completed

• Conditions: Systemic Lupus Erythematosus (SLE)

• Registration Number: NCT07071233
• Lead Sponsor: Universitas Sriwijaya

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-01
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30
• Study First Submitted: 2025-06-30
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-16
• Last Update Submitted: 2025-07-16
• Study First Posted: 2025-07-17
• Last Update Posted: 2025-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. All patients diagnosed with systemic lupus erythematosus with mild-moderate disease activity who are treated at the Allergy-Immunology Department of RSMH.
2. Patients aged over 18 years.
3. Willing to participate in the study by signing an informed consent form.

Exclusion Criteria

1. Pregnant or breastfeeding.
2. Patients with other immune disorders such as HIV, Rheumatoid Arthritis, Pulmonary Tuberculosis, chronic liver disease, and malignancies.
3. Patients currently taking supplements containing vitamin C for more than 1 week.
4. Patients with a diagnosis of SLE with severe disease activity or those who have reached remission.
5. Patients who are hospitalized due to SLE.
6. Patients with comorbid conditions such as hemochromatosis and gastritis.

Drop-out Criteria

1. Patients who discontinue vitamin C for more than 3 weeks.
2. Death.
3. Development of serious drug side effects, requiring discontinuation of the medication.
4. Patients who are readmitted or experience symptom deterioration during the intervention period.
5. Loss to follow-up.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
TNF-α	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.
MEX-SLEDAI score	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

Trial Locations

Locations (1)

Mohammad Hoesin General Hospital; 🇮🇩 Palembang, South Sumatera, Indonesia