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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01038024
• Other study ID #: I 155409
• Status: Completed
• Phase: N/A
• First received: December 18, 2009
• Last updated: March 7, 2013
• Start date: January 2010
• Est. completion date: July 2012

Study information

• Verified date: March 2013
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 2012
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cancer

Intervention

Dietary Supplement:
• 1 tablet composed of antioxidants and minerals
1 tablet daily

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish a base line level for 5 DNA modifications of White blood cells		2 years	No