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临床试验/NCT04781868
NCT04781868尚未招募早期 1 期

Multi-Nutrient Supplement for Radio-Protection

McMaster University0 个研究点目标入组 30 人开始时间: 2024年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
尚未招募
入组人数
30
主要终点
Number of gamma-H2Ax foci per PBMC nucleus

研究概览

简要总结

Exposure to radiation, such as during routine CTs, bone scans, or X-rays, causes oxidative stress which can damage the DNA (your genetic material) within your white blood cells. While the amount of DNA damage that may occur from one scan is not harmful to your overall health, there could be concerning damage in patients who are constantly exposed to this radiation. Currently, there is no way to prevent DNA damage during a medical scan. One potential way to fight the oxidative stress caused by radiation is to take an antioxidant before a scan. The purpose of this study is to see if a combination of antioxidants can protect someone from the damage that radiation causes to the DNA of their white blood cells.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 to 76 years.
  • Scheduled for bone scan procedure at the Juravinski Hospital.

排除标准

  • History of smoking within six months prior to study enrollment.
  • Known hypersensitivity reactions to any of the ingredients in the MNSRP.
  • Chemotherapy or radiation therapy within six months prior or one month following study enrollment.
  • Individuals currently taking vitamin or mineral supplements that contain antioxidants will be considered on a case-by-case basis but will be asked to refrain from intake for at least two weeks prior to partaking in this study.

研究组 & 干预措施

Multi-nutrient supplement

Experimental

干预措施: Multi-nutrient supplement (Drug)

Placebo supplement

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Number of gamma-H2Ax foci per PBMC nucleus

时间窗: Three hours following radiation exposure

Number of gamma-H2Ax foci per PBMC nucleus three hours following radiation exposure

次要结局

  • Abundance of phosphorus-ATM in PBMC's(Three hours following radiation exposure)
  • Amount of amplifiable mtDNA in PBMC's(Three hours following radiation exposure)
  • Abundance of mtDNA deletions in PBMC's(Three hours following radiation exposure)

研究者

申办方类型
Other
责任方
Sponsor

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