Multi-Nutrient Supplement for Radio-Protection

Early Phase 1

Not yet recruiting

• Conditions: Oxidative Stress; DNA Damage, Radiation Induced; Radiation Exposure
• Interventions: Drug: Multi-nutrient supplement; Drug: Placebo

• Registration Number: NCT04781868
• Lead Sponsor: McMaster University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-03-01
• Study First Posted: 2021-03-04
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-19
• Last Update Posted: 2023-10-23
• Study Start: 2024-07-01
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multi-nutrient supplement	Multi-nutrient supplement	-
Placebo supplement	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of gamma-H2Ax foci per PBMC nucleus	Three hours following radiation exposure	Number of gamma-H2Ax foci per PBMC nucleus three hours following radiation exposure

Secondary Outcome Measures

Name	Time	Method
Abundance of phosphorus-ATM in PBMC's	Three hours following radiation exposure	Abundance of phosphorus-ATM in PMBC's three hours following radiation exposure
Amount of amplifiable mtDNA 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	Abundance of mtDNA deletions in PBMC's three hours following radiation exposure