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NCT Number: NCT07083622

Efficacy of Vitamin C Supplementation on Malondialdehid Levels and Disease Activity in SLE Patients

The study aimed to evaluate the efficacy of vitamin C supplementation compared to placebo towards malondialdehid 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. Malondialdehid 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

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

About this study

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 malondialdehid levels and the degree of disease activity using MEX-SLEDAI score were measured before and after treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All patients diagnosed with mild to moderate systemic lupus erythematosus (SLE).
  • Patients aged over 18 years.
  • Willing to participate in the study by signing an informed consent form.

Exclusion criteria

  • Pregnant or breastfeeding patients.
  • Patients currently taking vitamin C supplementation within the past 3 days.
  • Patients with other immune-related disorders, either autoimmune or immunocompromised conditions, such as Human Immunodeficiency Virus (HIV) infection.
  • Patients with comorbid diseases.
  • Patients diagnosed with severe SLE or those who have achieved remission.
  • Patients with hemochromatosis.
  • Patients with a history of kidney stones.

Drop-Out Criteria

  • Death before the completion of the study.
  • Patients who stop taking the study medication for more than 3 weeks.
  • Occurrence of severe side effects or worsening of the disease.
  • Hospitalization or symptom worsening 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

    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. Malondialdehid

    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 malondialdehid levels concentration change in SLE patients.

Sponsors and collaborators

Lead sponsor

Universitas Sriwijaya

Other

Registry information

Official study title

The Efficacy of Vitamin C Supplementation on Malondialdehid Levels and Disease Activity in Systemic Lupus Erythematosus Patients

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 24, 2025
Registry last updated
Jul 24, 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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