The Efficacy of Vitamin C Supplementation on Serum IL-6 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
- 1
- 主要终点
- IL-6
研究概览
简要总结
The study aimed to evaluate the efficacy of vitamin C supplementation compared to placebo towards IL-6 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. IL-6 levels and MEX-SLEDAI score were evaluated at the beginning and at the end of the 8 week trial for analysis.
详细描述
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 IL-6 and the degree of disease activity using MEX-SLEDAI score were measured before and after treatment.
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
- •Patients with other immune disorders, both autoimmune and immunocompromised conditions such as human immunodeficiency virus (HIV)
- •Pregnant and breastfeeding patients.
- •Patients with malignancies.
- •Patients with chronic liver disorders.
- •Patients with infectious diseases.
- •Patients who consume supplements containing vitamin C.
- •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.
研究组 & 干预措施
Placebo
The patients were given a placebo capsule with a similar color, shape, size and taste twice a day
干预措施: Placebo (Dietary Supplement)
Vitamin C
The patients were given a tablet containing Vitamin C 500 mg twice a day
干预措施: Vitamin C (Dietary Supplement)
结局指标
主要结局
IL-6
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 IL-6 levels concentration change in SLE patients.
MEX-SLEDAI
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