Multi-Nutrient Supplement for Radio-Protection

NCT04781868 | Unknown Early Phase 1

• 1 other identifier: 13032
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Oxidative Stress; DNA Damage, Radiation Induced; Radiation Exposure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 phosphorus-ATM in PBMC's

  Three hours following radiation exposure

Study Arms (2)

Multi-nutrient supplement

EXPERIMENTAL

Drug: Multi-nutrient supplement

Placebo supplement

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Multi-nutrient supplement DRUG

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

Multi-nutrient supplement

Placebo DRUG

Placebo

Placebo supplement

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 4, 2021
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL