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

NCT07083622 | Completed DMC

• 1 other identifier: DP0403DXVIII0608ETIK2392024
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Systemic Lupus Erythematosus (SLE)

Keywords

systemic lupus erythematosus; SLE; vitamin c; Malondialdehid; Mex-SLEDAI; disease activity

Outcome Measures

Primary Outcomes (2)

• MEX-SLEDAI

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

  From enrollment to the end of the treatment at 8 weeks

• Malondialdehid

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

  From enrollment to the end of the treatment at 8 weeks

Study Arms (2)

Vitamin C

EXPERIMENTAL

The patients were given a tablet containing Vitamin C 500 mg twice a day

Dietary Supplement: Vitamin C

Placebo

PLACEBO COMPARATOR

The patients were given a placebo capsule with a similar color, shape, size and taste twice a day

Dietary Supplement: Placebo

Interventions

Vitamin C DIETARY_SUPPLEMENT

The patients received vitamin C supplementation

Vitamin C

Placebo DIETARY_SUPPLEMENT

Patients received placebo capsules

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Sriwijaya: lead

Study Sites (1)

Mohammad Hoesin General Hospital

Palembang, South Sumatera, 30126, Indonesia

Location

Related Publications (3)

• Bojanic, Z. et al. Effects of Methylprednisolone and Vitamin C Therapy on Malondialdehyde Level in Patients With Systemic Lupus Erythematosus. Acta Medica Median. 49, 10-15 (2010).

  BACKGROUND

• Minami Y, Sasaki T, Arai Y, Kurisu Y, Hisamichi S. Diet and systemic lupus erythematosus: a 4 year prospective study of Japanese patients. J Rheumatol. 2003 Apr;30(4):747-54.

  PMID: 12672194 BACKGROUND

• Atik N, Putri Pratiwi S, Hamijoyo L. Correlation between C-reactive Protein with Malondialdehyde in Systemic Lupus Erythematosus Patients. Int J Rheumatol. 2020 Jul 1;2020:8078412. doi: 10.1155/2020/8078412. eCollection 2020.

  PMID: 32695177 BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Triple (Participant, Care Provider, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Division of Allergy Immunology Faculty Member, Department of Internal Medicine, Universitas Sriwijaya/Mohammad Hoesin General Hospital

Model Details: The study was The study was designed as a single-center double-blind randomized controlled clinical trial. Participants were randomized into two groups receiving Vitamin C or placebo

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 24, 2025
• Study Start: September 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

ID (1)