- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01038024
Study for the Liquid Chromatography-mass Spectrometry (LC-MS/MS) Assessment of Oxidative DNA Damage in Relation to Antioxidant Usage
March 7, 2013 updated by: Roswell Park Cancer Institute
A Pilot Study for the 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
38
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Antioxidant Supplements
|
1 tablet daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To establish a base line level for 5 DNA modifications of White blood cells
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nathalie Zeitouni, MD, Roswell Park Cancer Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
February 1, 2011
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
December 18, 2009
First Submitted That Met QC Criteria
December 22, 2009
First Posted (Estimate)
December 23, 2009
Study Record Updates
Last Update Posted (Estimate)
March 8, 2013
Last Update Submitted That Met QC Criteria
March 7, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- I 155409
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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