The Efficacy of Vitamin C Supplementation on Malondialdehid 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
- MEX-SLEDAI
研究概览
简要总结
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.
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 malondialdehid levels 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 mild to moderate systemic lupus erythematosus (SLE).
- •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.
- •Patients currently taking vitamin C supplementation within the past 3 days.
- •Patients with other immune-related disorders, either autoimmune or immunocompromised conditions, such as Human Immunodeficiency Virus (HIV) infection.
- •Patients with comorbid diseases.
- •Patients diagnosed with severe SLE or those who have achieved remission.
- •Patients with hemochromatosis.
- •Patients with a history of kidney stones.
- •Drop-Out Criteria
- •Death before the completion of the study.
- •Patients who stop taking the study medication for more than 3 weeks.
- •Occurrence of severe side effects or worsening of the disease.
- •Hospitalization or symptom worsening 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
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
Malondialdehid
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 malondialdehid levels concentration change in SLE patients.
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