Multi-Nutrient Supplement for Radio-Protection (MNSRP)

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 Overview

• Status: Not yet recruiting
• Conditions: Oxidative Stress; Radiation Exposure; DNA Damage, Radiation Induced
• Intervention / Treatment: Drug: Placebo; Drug: Multi-nutrient supplement

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multi-nutrient supplement	Drug: Multi-nutrient supplement; Multi-nutrient supplement containing a combination of vitamins, minerals and antioxidants
Placebo Comparator: Placebo supplement	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of amplifiable mtDNA in PBMC's	Amount of amplifiable mtDNA in PBMC's three hours following radiation exposure	Three hours following radiation exposure
Abundance of mtDNA deletions in PBMC's	Abundance of mtDNA deletions in PBMC's three hours following radiation exposure	Three hours following radiation exposure
Abundance of phosphorus-ATM in PBMC's	Abundance of phosphorus-ATM in PMBC's three hours following radiation exposure	Three hours following radiation exposure

Collaborators and Investigators

• Sponsor: McMaster University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 19, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 13032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie results in a publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No