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

NCT07071233 | Completed DMC

• 1 other identifier: 04.03DXVIII0608ETIK204/2024
• 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 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.

Conditions

Systemic Lupus Erythematosus (SLE)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  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:

• 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.

Sponsors & Collaborators

• Universitas Sriwijaya: lead

Study Sites (1)

Mohammad Hoesin General Hospital

Palembang, South Sumatera, 30126, Indonesia

Location

Related Publications (2)

• Kong EH, Ma SY, Jeong JY, Kim KH. Effects of L-ascorbic acid on the production of pro-inflammatory and anti-inflammatory cytokines in C57BL/6 mouse splenocytes. KMJ. 2015 Jan 20;30(1):41-9.

  BACKGROUND

• Islam MA, Khandker SS, Kotyla PJ, Hassan R. Immunomodulatory Effects of Diet and Nutrients in Systemic Lupus Erythematosus (SLE): A Systematic Review. Front Immunol. 2020 Jul 22;11:1477. doi: 10.3389/fimmu.2020.01477. eCollection 2020.

  PMID: 32793202 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: June 30, 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)