Efficacy of Vitamin C Supplementation on Serum TNF-α Levels and Disease Activity in Systemic Lupus Erythematosus Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- TNF-α
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients diagnosed with systemic lupus erythematosus with mild-moderate disease activity who are treated at the Allergy-Immunology Department of RSMH.
- •Patients aged over 18 years.
- •Willing to participate in the study by signing an informed consent form.
排除标准
- •Pregnant or breastfeeding.
- •Patients with other immune disorders such as HIV, Rheumatoid Arthritis, Pulmonary Tuberculosis, chronic liver disease, and malignancies.
- •Patients currently taking supplements containing vitamin C for more than 1 week.
- •Patients with a diagnosis of SLE with severe disease activity or those who have reached remission.
- •Patients who are hospitalized due to SLE.
- •Patients with comorbid conditions such as hemochromatosis and gastritis.
- •Drop-out Criteria
- •Patients who discontinue vitamin C for more than 3 weeks.
- •Development of serious drug side effects, requiring discontinuation of the medication.
- •Patients who are readmitted or experience symptom deterioration during the intervention period.
- •Loss to follow-up.
结局指标
主要结局
TNF-α
时间窗: 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.
MEX-SLEDAI score
时间窗: 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
次要结局
未报告次要终点
研究者
Yuniza
Principal investigator, Division of Allergy Immunology Faculty Member, Department of Internal Medicine, Universitas Sriwijaya/Mohammad Hoesin General Hospital
Universitas Sriwijaya