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

Universitas Sriwijaya

Status: Completed

Conditions: Systemic Lupus Erythematosus (SLE)

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Vitamin C

Study type: Interventional

Funder types: Other

Identifiers

NCT07071233

04.03DXVIII0608ETIK204/2024

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. All patients diagnosed with systemic lupus erythematosus with mild-moderate disease activity who are treated at the Allergy-Immunology Department of RSMH.
2. Patients aged over 18 years.
3. Willing to participate in the study by signing an informed consent form.

Exclusion Criteria

1. Pregnant or breastfeeding.
2. Patients with other immune disorders such as HIV, Rheumatoid Arthritis, Pulmonary Tuberculosis, chronic liver disease, and malignancies.
3. Patients currently taking supplements containing vitamin C for more than 1 week.
4. Patients with a diagnosis of SLE with severe disease activity or those who have reached remission.
5. Patients who are hospitalized due to SLE.
6. Patients with comorbid conditions such as hemochromatosis and gastritis.

Drop-out Criteria

1. Patients who discontinue vitamin C for more than 3 weeks.
2. Death.
3. Development of serious drug side effects, requiring discontinuation of the medication.
4. Patients who are readmitted or experience symptom deterioration during the intervention period.
5. Loss to follow-up.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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38 participants in 2 patient groups, including a placebo group

Vitamin C

Experimental group

Description:

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

Treatment:

Dietary Supplement: Vitamin C

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo