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Plasma Citrulline Concentration in Tropical Enteropathy

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: NCT00816842
Recruitment Status : Completed
First Posted : January 5, 2009
Last Update Posted : January 5, 2009
Information provided by:
Azienda Ospedaliero-Universitaria di Parma

Brief Summary:
Citrulline is an amino acid produced in the intestine and in the liver, but the liver does not contribute significantly to circulating citrulline concentrations. The intestine is thus the only organ that normally releases significant amounts of citrulline into the blood stream. The investigators have designed a study looking at the value of measuring plasma citrulline concentration in patients with tropical enteropathy of mixed HIV status. The focus will be on the ability of the intestine to sustain the individual concerned from a nutritional standpoint. The investigators hypothesise that plasma citrulline concentration is a marker of small bowel absorptive integrity and an appropriate surrogate for HIV related enteropathy.

Condition or disease
Malabsorption Syndromes Granulomatous Enteritis Enteritis HIV Enteropathy Ileal Diseases

Detailed Description:
Preliminary studies reported that plasma citrulline concentrations may be a reliable biochemical marker for intestinal dysfunction and absorptive enterocyte mass. The relationship between citrulline concentration and intestinal function has been supported in other studies including those examining rejection in small bowel allografts. Concentrations of citrulline are dramatically reduced in cases of mucosal damage (e.g. moderate graft rejection or viral enteritis)and strongly correlate (inversely) with severity on biopsy. Plasma citrulline concentration is lower also in patients with villous atrophy (24±13µmol/L)than in healthy subjects (40±10µmol/L)and patients with anorexia nervosa (39±9µmol/L).Experimental studies have been carried out also in assessing the value of citrulline as a marker for severity of small bowel epithelial damage from radiation and viral infections. The plasma citrulline was shown to be a simple, non invasive and sensitive essay to monitor and quantify radiation and/or chemotherapy induced small bowel damage in mice and humans. Otherwise, the literature on citrulline as a potential marker of intestinal and nutritional integrity is young and consistent data for specific conditions as for HIV enteropathy are missing.We hypothesise that plasma citrulline concentration is a marker of small bowel absorptive integrity and an appropriate surrogate for HIV related enteropathy.

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Study Type : Observational
Official Title: Plasma Citrulline as Quantitative Biomarker of HIV Associate Villous Atrophy in a Tropical Enteropathy Population
Study Start Date : October 1998
Actual Primary Completion Date : May 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. postabsorptive plasma citrulline concentration [ Time Frame: within two years since enrolment date ]

Secondary Outcome Measures :
  1. intestinal permeability ratio [ Time Frame: within two years since enrolment date ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Tropical enteropathy with mixed HIV status

Inclusion Criteria:

  • histologically ascertained Tropical enteropathy
  • Mixed HIV status
  • Body mass index within normal range

Exclusion Criteria:

  • Patients with surgical resection of stomach, duodenum or pancreas; or (UGI) bypass.
  • Patients with other important disease, which may interfere with the study (especially diabetes and renal impairment). Alcoholism, drug abuse or any other circumstances, which may compromise the patient's ability to comply with the study requirements.
  • Pregnancy
  • Patients experiencing diarrhoea within one month since enrolment date
  • Use of glucagon-like peptide 2 (GLP2), growth hormone (GH) or glutamine or triglycerides
  • Coeliac Disease, Crohn's disease or infectious intestinal disease
  • Patients on steroids or FANS
  • Oral feeding>1.0-fold the estimated basal metabolic rate as assessed using Harris and Benedict equation

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): NCT00816842

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Department of Medicine, University of Zambia School of Medicine, University Teaching Hospital
Lusaka, Lusaka province, Zambia, P/B RW1X
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria di Parma
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Principal Investigator: Cinzia Papadia, MD Azienda Ospedaliero-Universitaria di Parma
Study Chair: Alastair Forbes, BSc MD FRCP ILTM University College London Hospitals
Study Director: Antonio Di Sabatino, MD University of Pavia
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Responsible Party: Cinzia Papadia, Azienda Ospedaliera Universitaria di Parma Identifier: NCT00816842    
Other Study ID Numbers: EC3184
Prot 84 24/01/06
First Posted: January 5, 2009    Key Record Dates
Last Update Posted: January 5, 2009
Last Verified: January 2009
Keywords provided by Azienda Ospedaliero-Universitaria di Parma:
Villous atrophy
Additional relevant MeSH terms:
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HIV Enteropathy
Intestinal Diseases
Malabsorption Syndromes
Sprue, Tropical
Crohn Disease
Ileal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Inflammatory Bowel Diseases