Multi-Nutrient Supplement for Radio-Protection

Early Phase 1UnknownNCT04781868

McMaster University30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Oxidative Stress DNA Damage, Radiation Induced Radiation Exposure

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 74 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of gamma-H2Ax foci per PBMC nucleus

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

Time frame: Three hours following radiation exposure

Secondary Outcomes

Amount of amplifiable mtDNA in PBMC's

Amount of amplifiable mtDNA in PBMC's three hours following radiation exposure

Time frame: Three hours following radiation exposure

Abundance of mtDNA deletions in PBMC's

Abundance of mtDNA deletions in PBMC's three hours following radiation exposure

Time frame: Three hours following radiation exposure

Abundance of phosphorus-ATM in PBMC's

Abundance of phosphorus-ATM in PMBC's three hours following radiation exposure

Time frame: Three hours following radiation exposure