Oxidative Damage and Inflammation in Obese Diabetic Emirati Subjects Supplemented With Antioxidants and B-vitamins: a Randomized Placebo-controlled Trail
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Inflammation
研究概览
简要总结
Substantial evidence shows that diets incorporating antioxidants and B-group vitamins can offer significant protection against infections and cardiovascular disease (CVD) especially in diabetic patients. The proposed study will determine whether improvements in antioxidants and B-group vitamins in diabetic patients who are known to have a high risk of CVD will lead to a clinical benefit
详细描述
Following informed written consent 96 diabetic patients will be randomly assigned to receive either an oral dose of daily B-group vitamins (5 mg folic acid, 5mg vitamin B-2, 50 mg vitamin B-6, 0.4 mg vitamin B-12) and antioxidant vitamins [800 IU (727mg) of a-tocopherol and 500mg of vitamin C] [n=48], or no supplements [n= 48] daily for 90 days. All subjects will have three assessments, at baseline, 3, and 12 months post-randomisation. The assessment will include markers of inflammation, endothelial dysfunction, oxidative stress, antioxidants, total plasma homocysteine and risk of infections. A fasting 15-ml of blood will be taken for measurements of total plasma homocysteine concentration, markers of inflammation, endothelial dysfunction, oxidative damage and vitamin concentrations. Further information on clinical variables which may influence endothelial dysfunction, antioxidant capacity, immunity and diabetes control status will be collected and adjusted for during analysis.
Potential Significance- the study will help to clarify the temporal relationships between , markers of inflammation, endothelial dysfunction and oxidative stress and risk of infections and form the basis of appropriate intervention strategies to minimise the long-term complications associated with type 2 diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Type 2 Diabetes mellitus
排除标准
- •severe chronic clinical or psychiatric disease,
- •participating in other intervention trials,
- •on dietary supplements and
- •those unable to give an informed written consent
研究组 & 干预措施
vitamins pills
antioxidant and B vitamins vitamins vitamin
干预措施: vitamins (Dietary Supplement)
pills
MICROCRYSTALLINE CELLULOSE
干预措施: Placebo (Drug)
结局指标
主要结局
Inflammation
时间窗: 3 months
Oxidative damage
时间窗: 3 months
次要结局
- Antioxidant status(3 months)
研究者
Salah Gariballa
Professor
United Arab Emirates University
