Efficacy of Vitamin C Supplementation on Serum IL-6 Levels and Disease Activity in Systemic Lupus Erythematosus Patients

Not Applicable

Completed

• Conditions: Systemic Lupus Erythematosus (SLE)

• Registration Number: NCT07071220
• Lead Sponsor: Universitas Sriwijaya

Brief Summary

The study aimed to evaluate the efficacy of vitamin C supplementation compared to placebo towards IL-6 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. IL-6 levels and MEX-SLEDAI score were evaluated at the beginning and at the end of the 8 week trial for analysis.

Detailed Description

This research is a double blind randomized controlled trial study. The study subjects were 38 patients diagnosed with mild to moderate lupus activity, randomly divided into 2 groups, who received vitamin C supplementation twice daily for 8 weeks and the group that received placebo. Serum IL-6 and the degree of disease activity using MEX-SLEDAI score were measured before and after treatment.

Study Timeline

• Study Start: 2024-09-01
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30
• Status Verified: 2025-07
• Study First Submitted: 2025-07-01
• 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. Patients with other immune disorders, both autoimmune and immunocompromised conditions such as human immunodeficiency virus (HIV)
2. Pregnant and breastfeeding patients.
3. Patients with malignancies.
4. Patients with chronic liver disorders.
5. Patients with infectious diseases.
6. Patients who consume supplements containing vitamin C.

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
IL-6	From enrollment to the end of the treatment at 8 weeks	To determine the effectiveness of adding vitamin C compared to placebo towards IL-6 levels concentration change in SLE patients.
MEX-SLEDAI	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