Study for the Liquid Chromatography-mass Spectrometry (LC-MS/MS) Assessment of Oxidative DNA Damage in Relation to Antioxidant Usage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01038024
Recruitment Status : Completed
First Posted : December 23, 2009
Last Update Posted : March 8, 2013
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief Summary:
The purpose of this study is to evaluate the basis for the reported good effects of antioxidant supplementation. A blood test using Mass Spectrometry will measure DNA damage which is expected to decrease with antioxidant administration and therefore decrease the risk of cancer.

Condition or disease Intervention/treatment
Cancer Dietary Supplement: 1 tablet composed of antioxidants and minerals

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Study for the LC-MS/MS Assessment of Oxidative DNA Damage in Relation to Antioxidant Usage
Study Start Date : January 2010
Primary Completion Date : February 2011
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Antioxidant Supplements Dietary Supplement: 1 tablet composed of antioxidants and minerals
1 tablet daily

Primary Outcome Measures :
  1. To establish a base line level for 5 DNA modifications of White blood cells [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 years.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01038024

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
Principal Investigator: Nathalie Zeitouni, MD Roswell Park Cancer Institute

Responsible Party: Roswell Park Cancer Institute Identifier: NCT01038024     History of Changes
Other Study ID Numbers: I 155409
First Posted: December 23, 2009    Key Record Dates
Last Update Posted: March 8, 2013
Last Verified: March 2013

Keywords provided by Roswell Park Cancer Institute:
antioxidant supplement

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs