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

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Dietary Supplement: 1 tablet composed of antioxidants and minerals

• Registration Number: NCT01038024
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2009-12-18
• Study First Submitted QC: 2009-12-22
• Study First Posted: 2009-12-23
• Study Start: 2010-01
• Primary Completion: 2011-02
• Study Completion: 2012-07
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-07
• Last Update Posted: 2013-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Antioxidant Supplements	1 tablet composed of antioxidants and minerals	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States