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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01038024

Enrollment

Registered

2009-12-23

Start date

2010-01-31

Completion date

2012-07-31

Last updated

2013-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

antioxidant supplement

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.

Interventions

DIETARY_SUPPLEMENT1 tablet composed of antioxidants and minerals

1 tablet daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
To establish a base line level for 5 DNA modifications of White blood cells	2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026