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

NCT07071220 | Completed DMC

• 1 other identifier: 04.03/DXVIII0608ETIK/237/2024
• 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 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.

Conditions

Systemic Lupus Erythematosus (SLE)

Keywords

systemic lupus erythematosus; SLE; vitamin C; IL-6; Mex-SLEDAI; disease activity

Outcome Measures

Primary Outcomes (2)

• IL-6

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

  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

  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 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.

You may not qualify if:

• Patients with other immune disorders, both autoimmune and immunocompromised conditions such as human immunodeficiency virus (HIV)
• Pregnant and breastfeeding patients.
• Patients with malignancies.
• Patients with chronic liver disorders.
• Patients with infectious diseases.
• Patients who consume supplements containing vitamin C.
• 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.

Sponsors & Collaborators

• Universitas Sriwijaya: lead

Study Sites (1)

Mohammad Hoesin General Hospital

Palembang, South Sumatera, 30126, Indonesia

Location

Related Publications (3)

• 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

• Tam LS, Li EK, Leung VY, Griffith JF, Benzie IF, Lim PL, Whitney B, Lee VW, Lee KK, Thomas GN, Tomlinson B. Effects of vitamins C and E on oxidative stress markers and endothelial function in patients with systemic lupus erythematosus: a double blind, placebo controlled pilot study. J Rheumatol. 2005 Feb;32(2):275-82.

  PMID: 15693087 BACKGROUND

• Ellulu MS, Rahmat A, Patimah I, Khaza'ai H, Abed Y. Effect of vitamin C on inflammation and metabolic markers in hypertensive and/or diabetic obese adults: a randomized controlled trial. Drug Des Devel Ther. 2015 Jul 1;9:3405-12. doi: 10.2147/DDDT.S83144. eCollection 2015.

  PMID: 26170625 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 17, 2025
• Study Start: September 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

ID (1)