Systemic Lupus Erythematosus (SLE)
Conditions
Keywords
systemic lupus erythematosus, SLE, vitamin c, Malondialdehid, Mex-SLEDAI, disease activity
Brief summary
The study aimed to evaluate the efficacy of vitamin C supplementation compared to placebo towards malondialdehid 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. Malondialdehid levels and MEX-SLEDAI score were evaluated at the beginning and at the end of the 8 week trial for analysis.
Detailed description
This research is a double blind randomized controlled trial study. The study subjects were 38 patients diagnosed with mild to moderate lupus activity, randomly divided into 2 groups, who received vitamin C supplementation twice daily for 8 weeks and the group that received placebo. Serum malondialdehid levels and the degree of disease activity using MEX-SLEDAI score were measured before and after treatment.
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 mild to moderate systemic lupus erythematosus (SLE). 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 patients. 2. Patients currently taking vitamin C supplementation within the past 3 days. 3. Patients with other immune-related disorders, either autoimmune or immunocompromised conditions, such as Human Immunodeficiency Virus (HIV) infection. 4. Patients with comorbid diseases. 5. Patients diagnosed with severe SLE or those who have achieved remission. 6. Patients with hemochromatosis. 7. Patients with a history of kidney stones. Drop-Out Criteria 1. Death before the completion of the study. 2. Patients who stop taking the study medication for more than 3 weeks. 3. Occurrence of severe side effects or worsening of the disease. 4. Hospitalization or symptom worsening during the intervention period. 5. Loss to follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MEX-SLEDAI | 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 |
| Malondialdehid | From enrollment to the end of the treatment at 8 weeks | To determine the effectiveness of adding vitamin C compared to placebo towards malondialdehid levels concentration change in SLE patients. |
Countries
Indonesia
Outcome results
None listed