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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01091558
Recruitment Status : Completed
First Posted : March 24, 2010
Last Update Posted : March 31, 2017
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Keith Wilson, Vanderbilt University Medical Center

Brief Summary:

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.

Condition or disease
Ulcerative Colitis Colon Cancer

Detailed Description:
Amino acids are being measured in colon tissues and in serum by high performance liquid chromotography (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 polymerase chain reaction (PCR) analysis of mRNA expression.

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Study Type : Observational
Actual Enrollment : 204 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Immunomodulary Effects of Arginine Supplementation in Colitis and Colon Cancer
Study Start Date : September 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Healthy volunteer who is having a screening colonoscopy
Ulcerative Colitis
Patients with confirmed ulcerative colitis who are scheduled for endoscopy for medical reasons.

Primary Outcome Measures :
  1. L-Arginine (L-Arg) availability in ulcerative colitis (UC) patients and normal control subjects, and correlate with disease activity [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. L-Arg intake in the diet of UC patients and control subjects [ Time Frame: 24 months ]

Biospecimen Retention:   Samples Without DNA
blood, urine and tissue

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Any patient scheduled to have a colonoscopy as part of medical care for either ulcerative colitis or as a routine screening colonoscopy.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01091558

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United States, Tennessee
Vanderbilt Hospital
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
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Principal Investigator: Keith Wilson, MD, AGAF Vanderbilt University Medical Center
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Responsible Party: Keith Wilson, Professor of Medicine, Vanderbilt University Medical Center Identifier: NCT01091558    
Other Study ID Numbers: 090943
3R01AT004821-02S1 ( U.S. NIH Grant/Contract )
First Posted: March 24, 2010    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Keith Wilson, Vanderbilt University Medical Center:
ulcerative colitis
colon cancer
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Colitis, Ulcerative
Pathologic Processes