Multi-Nutrient Supplement for Radio-Protection

Study Overview
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Brief Summary
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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.

Official Title
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Multi-Nutrient Supplement for Radio-Protection

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

Intervention / Treatment
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* Drug: Multi-nutrient supplement
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |