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Clinical Trials/NCT01038024
NCT01038024
Completed
Not Applicable

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

Roswell Park Cancer Institute1 site in 1 country38 target enrollmentStarted: January 2010Last updated:
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ConditionsCancer

Overview

Phase
Not Applicable
Status
Completed
Enrollment
38
Locations
1
Primary Endpoint
To establish a base line level for 5 DNA modifications of White blood cells
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

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

Time Frame: 2 years

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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