Study for the Liquid Chromatography-mass Spectrometry (LC-MS/MS) Assessment of Oxidative DNA Damage in Relation to Antioxidant Usage
This study has been completed.
Sponsor:
Roswell Park Cancer Institute
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01038024
First received: December 18, 2009
Last updated: March 7, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cancer |
Dietary Supplement: 1 tablet composed of antioxidants and minerals |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Pilot Study for the LC-MS/MS Assessment of Oxidative DNA Damage in Relation to Antioxidant Usage |
Resource links provided by NLM:
Further study details as provided by Roswell Park Cancer Institute:
Primary Outcome Measures:
- To establish a base line level for 5 DNA modifications of White blood cells [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 38 |
| Study Start Date: | January 2010 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Antioxidant Supplements |
Dietary Supplement: 1 tablet composed of antioxidants and minerals
1 tablet daily
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038024
Locations
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263 | |
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
| Principal Investigator: | Nathalie Zeitouni, MD | Roswell Park Cancer Institute |
More Information
No publications provided
| Responsible Party: | Roswell Park Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01038024 History of Changes |
| Other Study ID Numbers: | I 155409 |
| Study First Received: | December 18, 2009 |
| Last Updated: | March 7, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Roswell Park Cancer Institute:
|
antioxidant supplement |
Additional relevant MeSH terms:
|
Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013