The Effects of Zinc Gluconate Supplementation on Several Genes Expression, the Serum Level of Inflammatory Factors, Quality of Life, and Disease Activity in Patients With Behcet Syndrome: Double-blind Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Serum level of zinc
研究概览
简要总结
To study the effects of zinc gluconate supplementation on patients with Behçet's syndrome, 50 patients will be randomly allocated to two groups: placebo group or zinc group (one tablet of 30 mg/day elemental zinc) for 12 weeks. All participants will be asked not to alter their diet, medication, and physical activity during the study. At the first and the end of the intervention, genes and proteins expression, the serum level of inflammatory factors, quality of life, disease activity, anthropometric measures, physical activity and serum level of zinc will be assessed and compared between groups.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range 20 to 50 years (premenopausal woman)
- •Diagnosis of Behcet's disease by a rheumatologist according to IBCD (The International Criteria for Behcet's Disease)
- •Patients who want to participate in the study
排除标准
- •Pregnancy and lactation
- •History of diabetes and other chronic diseases
- •Smoking and alcohol consumption over the past year
- •History of other autoimmune diseases
- •Consumption of nutritional and antioxidant supplements over two months prior to the study
结局指标
主要结局
Serum level of zinc
时间窗: 12 weeks
ug/dl
Toll-like Receptor-4 gene expression
时间窗: 12 weeks
2-ΔΔCT
Toll-like Receptor-2 protein expression
时间窗: 12 weeks
The mean fluorescence intensity
Toll-like Receptor-4 protein expression
时间窗: 12 weeks
The mean fluorescence intensity
Caspase-1 gene expression
时间窗: 12 weeks
2-ΔΔCT
Serum level of interleukin-1 beta
时间窗: 12 weeks
pg/ml
Toll-like Receptor-2 gene expression
时间窗: 12 weeks
2-ΔΔCT
Serum level of tumor necrosis factor-alpha
时间窗: 12 weeks
pg/ml
NLRP3 gene expression
时间窗: 12 weeks
2-ΔΔCT
次要结局
- Behçet's disease quality-of-life(12 weeks)
- Disease activity(12 weeks)
研究者
Beitullah Alipour
Beitullah Alipour, Ph.D., Prof.
Tabriz University of Medical Sciences