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A Pilot Study for the LC-MS/MS Assessment of Oxidative DNA Damage in Relation to Antioxidant Usage

18 Years
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Trial Information

A Pilot Study for the LC-MS/MS Assessment of Oxidative DNA Damage in Relation to Antioxidant Usage

In this pilot study, the overall purpose is to establish the molecular basis for the
hypothesis that oxidative stress is a risk factor for cancer. This will be achieved by
establishing base line levels of oxidative DNA damage in a population of healthy individuals
before and after taking antioxidant and mineral supplements for 8 weeks.

Inclusion Criteria:

- Health male or female non-melanoma patients or volunteers

- 18 years or older with a life expectancy greater than 6 months

- Willing to provide pre and post blood samples to measure five DNA modifications in
white blood cells

- Willing to participate in a one tablet a day eight week supplement program and to
record the ingestion of the supplement on a participant calendar

- Must have never smoked or has not smoked for at least 6 months

- Informed of the investigational nature of the study, is able to provide informed
consent and has signed thee informed consent form

Exclusion Criteria:

- Patients/healthy volunteers not meeting all of the above selection criteria.

- Patients/healthy volunteers who have a history of kidney stones within the last 5

- Any participant with life threatening conditions including but not limited to cardiac
failure, congestive heart failure, unstable coronary artery disease, uncontrolled
hypertension, poorly controlled diabetes mellitus, kidney and liver disease,severe
metabolic disorders and advanced cancer

- Patients not willing to comply with protocol requirements

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

To establish a base line level for 5 DNA modifications of White blood cells

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Nathalie Zeitouni, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute


United States: Institutional Review Board

Study ID:

I 155409



Start Date:

January 2010

Completion Date:

July 2012

Related Keywords:

  • Cancer
  • antioxidant supplement



Roswell Park Cancer Institute Buffalo, New York  14263