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

Universitas Sriwijaya38 enrolled

Overview

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 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. 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.

Outcomes

Primary Outcomes

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

Time frame: 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.