Multi-Nutrient Supplement for Radio-Protection

Oxidative Stress Clinical Trial

— MNSRP  

Official title:

Multi-Nutrient Supplement for Radio-Protection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04781868
• Other study ID #: 13032
• Status: Not yet recruiting
• Phase: Early Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• DNA Damage, Radiation Induced
• Oxidative Stress
• Radiation Exposure

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