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Curcumin Biomarkers

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ClinicalTrials.gov Identifier: NCT01333917
Recruitment Status : Completed
First Posted : April 12, 2011
Last Update Posted : February 7, 2013
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE April 6, 2011
First Posted Date  ICMJE April 12, 2011
Last Update Posted Date February 7, 2013
Study Start Date  ICMJE November 2010
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2011)
  • Gene expression [ Time Frame: 30 days ]
    Change in gene expression
  • Ribonucleic acid (RNA) level [ Time Frame: 30 days ]
    Transcript level as mRNA copies per cell
  • Apoptosis [ Time Frame: 30 days ]
    Immunohistochemistry (IHC) signal as intensity and proportion of cells stained
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01333917 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2011)
Number of Participants with Adverse Events [ Time Frame: 30 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Curcumin Biomarkers
Official Title  ICMJE Curcumin Chemoprevention of Colorectal Neoplasia
Brief Summary Colorectal cancer is a major problem in the United States and other developed countries. A safe and effective chemopreventive agent could reduce the burden of colorectal neoplasia. Curcumin, is a product that is derived from Curcuma longa. It has been used for thousands of years as a traditional remedy. Curcumin blocks a number of targets involved in tumor initiation, promotion, and progression, and is considered a promising chemopreventive agent. The investigators propose to enroll 40 patients after screening colonoscopy who will have rectal biopsies at baseline and after 4 weeks of curcumin 4 grams per day. The investigators will use microarray analysis to identify genes that are modified by curcumin that could be used as biomarkers in future chemoprevention studies. The study will also evaluate tolerability and toxicity.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE Drug: Curcumin C3 tablet
4 grams Curcumin C3 tablet daily x30 days
Study Arms  ICMJE Experimental: Curcumin
4g Curcumin C3 tablet daily
Intervention: Drug: Curcumin C3 tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 11, 2011)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 40 - 80.
  2. A willingness to follow the study protocol, as indicated by provision of informed consent to participate
  3. Good general health

Exclusion Criteria:

  1. Familial colorectal cancer syndromes (e.g. Hereditary Non-Polyposis Colon Cancer, Familial Adenomatous Polyposis)
  2. Ulcerative colitis or Crohn's disease.
  3. History of large bowel resection for any reason
  4. Diagnosed narcotic or alcohol dependence
  5. Unwillingness to forgo curcumin/turmeric-containing supplements during the trial or consumption of curry/turmeric at meals > 3 times a week.
  6. Allergy to turmeric/curcumin.
  7. Women with childbearing potential who do not agree to practice effective birth control.
  8. Individuals with creatinine, AST or ALT above 1.5 times the upper limit of normal at baseline.
  9. Personal or inherited bleeding disorders or therapeutic anti-coagulation with warfarin.
  10. Women who are pregnant or nursing.
  11. Individuals who have taken antibiotics within the three months prior to enrollment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01333917
Other Study ID Numbers  ICMJE 10-1524
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gary N Asher, MD, MPH University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP