Systemic Lupus Erythematosus (SLE)
Conditions
Keywords
systemic lupus erythematosus, SLE, vitamin c, TNF-alpha, Mex-SLEDAI, disease activity
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.
Interventions
DIETARY_SUPPLEMENTVitamin C
The patients received vitamin C supplementation
DIETARY_SUPPLEMENTPlacebo
Patients received placebo capsules
Sponsors
Universitas Sriwijaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Triple (Participant, Care Provider, Investigator)
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MEX-SLEDAI score | From enrollment to the end of the treatment at 8 weeks | To determine the effectiveness of adding vitamin C compared to placebo towards disease activity in SLE patients, measured with MEX-SLEDAI score |
| TNF-α | From enrollment to the end of the treatment at 8 weeks | To determine the effectiveness of adding vitamin C compared to placebo towards TNF-α levels concentration change in SLE patients. |
Countries
Indonesia
Outcome results
None listed