Vitamin C Supplementation for Systemic Lupus Erythematosus
Vitamin C
+ Placebo
Autoimmune Diseases+2
+ Connective Tissue Diseases
+ Immune System Diseases
Treatment Study
Summary
Study start date: September 1, 2024
Actual date on which the first participant was enrolled.This study aims to investigate whether taking Vitamin C can help reduce inflammation and improve symptoms in people with a condition called Systemic Lupus Erythematosus (SLE), which is an autoimmune disease affecting multiple parts of the body. The research focuses on patients with mild to moderate lupus activity and seeks to understand if Vitamin C can lower levels of a specific inflammation marker called IL-6 in the blood and improve disease activity. By exploring this, the study hopes to find a simple treatment option that might help manage lupus symptoms and improve patients' quality of life. Participants in the study are divided into two groups. One group receives Vitamin C supplements, while the other group takes a placebo, which is a harmless pill that has no effect. Both groups take their assigned pills twice a day for eight weeks. The researchers measure the level of IL-6 in the blood and assess lupus disease activity using a score called MEX-SLEDAI before and after the treatment. This helps determine if there is any noticeable change in inflammation and disease symptoms due to Vitamin C supplementation. The study is double-blind, meaning neither the participants nor the researchers know who receives the real supplement or the placebo during the trial, ensuring unbiased results.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.38 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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. Patients with other immune disorders, both autoimmune and immunocompromised conditions such as human immunodeficiency virus (HIV) 2. Pregnant and breastfeeding patients. 3. Patients with malignancies. 4. Patients with chronic liver disorders. 5. Patients with infectious diseases. 6. Patients who consume supplements containing vitamin C. 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Mohammad Hoesin General Hospital
Palembang, IndonesiaOpen Mohammad Hoesin General Hospital in Google Maps