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临床试验/NCT01691365
NCT01691365已完成4 期

Oxidative Damage and Inflammation in Obese Diabetic Emirati Subjects Supplemented With Antioxidants and B-vitamins: a Randomized Placebo-controlled Trail

United Arab Emirates University0 个研究点目标入组 100 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

antioxidant and B vitamins vitamins vitamin


干预措施: vitamins (Dietary Supplement)

pills

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Salah Gariballa

Professor

United Arab Emirates University

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