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Multi-Nutrient Supplement for Radio-Protection (MNSRP)

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ClinicalTrials.gov Identifier: NCT04781868
Recruitment Status : Not yet recruiting
First Posted : March 4, 2021
Last Update Posted : March 4, 2021
Sponsor:
Information provided by (Responsible Party):
McMaster University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Oxidative Stress DNA Damage, Radiation Induced Radiation Exposure Drug: Multi-nutrient supplement Drug: Placebo Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Multi-Nutrient Supplement for Radio-Protection
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Number of gamma-H2Ax foci per PBMC nucleus [ Time Frame: Three hours following radiation exposure ]
    Number of gamma-H2Ax foci per PBMC nucleus three hours following radiation exposure


Secondary Outcome Measures :
  1. Amount of amplifiable mtDNA in PBMC's [ Time Frame: Three hours following radiation exposure ]
    Amount of amplifiable mtDNA in PBMC's three hours following radiation exposure

  2. Abundance of mtDNA deletions in PBMC's [ Time Frame: Three hours following radiation exposure ]
    Abundance of mtDNA deletions in PBMC's three hours following radiation exposure

  3. Abundance of phosphorus-ATM in PBMC's [ Time Frame: Three hours following radiation exposure ]
    Abundance of phosphorus-ATM in PMBC's three hours following radiation exposure


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT04781868    
Other Study ID Numbers: 13032
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No