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MNSRP: Multi-Nutrient Supplement for Radio-Protection

Sponsor
McMaster University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04781868
Collaborator
(none)
30
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

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
  • Drug: Multi-nutrient supplement
  • Drug: Placebo
 Early Phase 1

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. 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

  1. Amount of amplifiable mtDNA in PBMC's [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 [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 [Three hours following radiation exposure]

    Abundance of phosphorus-ATM in PMBC's three hours following radiation exposure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 74 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

No locations specified.

Sponsors and Collaborators

  • McMaster University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
McMaster University
ClinicalTrials.gov Identifier:
NCT04781868
Other Study ID Numbers:
  • 13032
First Posted:
Mar 4, 2021
Last Update Posted:
Mar 4, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 4, 2021