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NCT Number: NCT07071233

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

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Key information

Conditions

Systemic Lupus Erythematosus (SLE) Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohammad Hoesin General Hospital

Palembang, South Sumatera, 30126, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

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.

Treatment and study plan

Vitamin C

Dietary Supplement

The patients received vitamin C supplementation

Placebo

Dietary Supplement

Patients received placebo capsules

Primary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Universitas Sriwijaya

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 17, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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