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Study of Effects of L-Arginine in Colitis and Colon Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by (Responsible Party):
Keith Wilson, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01091558
First received: March 18, 2010
Last updated: December 6, 2011
Last verified: December 2011
History of Changes

March 18, 2010
December 6, 2011
September 2009
September 2011   (final data collection date for primary outcome measure)
L-Arginine (L-Arg) availability in ulcerative colitis (UC) patients and normal control subjects, and correlate with disease activity [ Time Frame: 24 months ] [ Designated as safety issue: No ]
L-Arg availability in UC patients and normal control subjects, and correlate with disease activity [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01091558 on ClinicalTrials.gov Archive Site
L-Arg intake in the diet of UC patients and control subjects [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Effects of L-Arginine in Colitis and Colon Cancer
Immunomodulary Effects of Arginine Supplementation in Colitis and Colon Cancer

The purpose of this study is to look at the importance of L-Arginine in the digestive tract. L-Arginine is an amino acid and is important in making proteins within the cell.

The evaluation of colon tissue, blood, urine, diet, health history, and symptoms will help us learn more about L-Arginine and ulcerative colitis. The investigators believe these studies will provide new insights into the treatment for Inflammatory Bowel Disease (ulcerative colitis) and nutritional needs. The investigators plan to enroll 200 participants in this study over the next two years.

Amino acids are being measured in colon tissues and in serum by HPLC. Cytokines and chemokines are being measured in colon tissues and in serum by Luminex assay. Cytokines and chemokines are also being measured in colon tissues by real-time PCR analysis of mRNA expression.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

blood, urine and tissue
Non-Probability Sample

Any patient scheduled to have a colonoscopy as part of medical care for either ulcerative colitis or as a routine screening colonoscopy.
  • Ulcerative Colitis
  • Colon Cancer
Not Provided
  • Colonoscopy
    Healthy volunteer who is having a screening colonoscopy
  • Ulcerative Colitis
    Patients with confirmed ulcerative colitis who are scheduled for endoscopy for medical reasons.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
Not Provided
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years of age or older
  • Colonoscopy for one of the following: clinical indications, disease assessment, or surveillance for dysplasia (as in ulcerative colitis)
  • Screening for cancer

Exclusion Criteria:

  • refusal to participate
  • age less than 18 years at time of colonoscopy
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01091558
090943, 3R01AT004821-02S1
Yes
Keith Wilson, Vanderbilt University
Vanderbilt University
  • National Institutes of Health (NIH)
  • National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Keith Wilson, MD, AGAF Vanderbilt University
Vanderbilt University
December 2011

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