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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2024-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Systemic Lupus Erythematosus (SLE)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Triple (Participant, Care Provider, Investigator)

Study Groups

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Vitamin C

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

Group Type EXPERIMENTAL

Vitamin C

Intervention Type DIETARY_SUPPLEMENT

The patients received vitamin C supplementation

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Patients received placebo capsules

Interventions

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Vitamin C

The patients received vitamin C supplementation

Intervention Type DIETARY_SUPPLEMENT

Placebo

Patients received placebo capsules

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Yuniza

Principal investigator, Division of Allergy Immunology Faculty Member, Department of Internal Medicine, Universitas Sriwijaya/Mohammad Hoesin General Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR