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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01038024
First received: December 18, 2009
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

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 Intervention
Cancer
Dietary Supplement: 1 tablet composed of antioxidants and minerals

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • To establish a base line level for 5 DNA modifications of White blood cells [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: January 2010
Study Completion Date: July 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antioxidant Supplements Dietary Supplement: 1 tablet composed of antioxidants and minerals
1 tablet daily

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01038024

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

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01038024     History of Changes
Other Study ID Numbers: I 155409
Study First Received: December 18, 2009
Last Updated: March 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Roswell Park Cancer Institute:
antioxidant supplement

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

ClinicalTrials.gov processed this record on August 28, 2014