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

Universitas Sriwijaya38 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Systemic Lupus Erythematosus (SLE)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

IL-6

To determine the effectiveness of adding vitamin C compared to placebo towards IL-6 levels concentration change in SLE patients.

Time frame: From enrollment to the end of the treatment at 8 weeks

MEX-SLEDAI

To determine the effectiveness of adding vitamin C compared to placebo towards disease activity in SLE patients, measured with MEX-SLEDAI score