Skip to main content
OpenTrials
Completed

NCT Number: NCT01038024

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1 tablet composed of antioxidants and minerals

Dietary Supplement

1 tablet daily

Primary outcomes

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

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Dec 23, 2009
Registry last updated
Mar 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.