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NCT01091558 Clinical Trial

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

Ulcerative Colitis Clinical Trial

Official title:
Immunomodulary Effects of Arginine Supplementation in Colitis and Colon Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01091558
Other study ID # 090943
Secondary ID 3R01AT004821-02S
Status Completed
Phase N/A
First received March 18, 2010
Last updated March 30, 2017
Start date September 2009
Est. completion date December 2011

Study information
Verified date March 2017
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 204
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Vanderbilt Hospital Nashville Tennessee

Sponsors (3)
Lead Sponsor Collaborator
Vanderbilt University Medical Center National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary L-Arginine (L-Arg) availability in ulcerative colitis (UC) patients and normal control subjects, and correlate with disease activity 24 months
Secondary L-Arg intake in the diet of UC patients and control subjects 24 months
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