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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04781868
Other study ID # 13032
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date July 1, 2024
Est. completion date July 1, 2025

Study information

Verified date October 2023
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date July 1, 2025
Est. primary completion date July 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 74 Years
Eligibility Inclusion Criteria: - Age 18 to 76 years. - Scheduled for bone scan procedure at the Juravinski Hospital. Exclusion Criteria: - 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.

Study Design


Intervention

Drug:
Multi-nutrient supplement
Multi-nutrient supplement containing a combination of vitamins, minerals and antioxidants
Placebo
Placebo

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
McMaster University

Outcome

Type Measure Description Time frame Safety issue
Primary Number of gamma-H2Ax foci per PBMC nucleus Number of gamma-H2Ax foci per PBMC nucleus three hours following radiation exposure Three hours following radiation exposure
Secondary Amount of amplifiable mtDNA in PBMC's Amount of amplifiable mtDNA in PBMC's three hours following radiation exposure Three hours following radiation exposure
Secondary Abundance of mtDNA deletions in PBMC's Abundance of mtDNA deletions in PBMC's three hours following radiation exposure Three hours following radiation exposure
Secondary Abundance of phosphorus-ATM in PBMC's Abundance of phosphorus-ATM in PMBC's three hours following radiation exposure Three hours following radiation exposure
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