Plasma Citrulline Concentration in Tropical Enteropathy
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ClinicalTrials.gov Identifier: NCT00816842 |
Recruitment Status
:
Completed
First Posted
: January 5, 2009
Last Update Posted
: January 5, 2009
|
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Condition or disease |
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Malabsorption Syndromes Granulomatous Enteritis Enteritis HIV Enteropathy Ileal Diseases |
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 |

- postabsorptive plasma citrulline concentration [ Time Frame: within two years since enrolment date ]
- intestinal permeability ratio [ Time Frame: within two years since enrolment date ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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 ClinicalTrials.gov identifier (NCT number): NCT00816842
Zambia | |
Department of Medicine, University of Zambia School of Medicine, University Teaching Hospital | |
Lusaka, Lusaka province, Zambia, P/B RW1X |
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 |
Responsible Party: | Cinzia Papadia, Azienda Ospedaliera Universitaria di Parma |
ClinicalTrials.gov Identifier: | NCT00816842 History of Changes |
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:
citrulline malabsorption Villous atrophy enteropathy |
Additional relevant MeSH terms:
Intestinal Diseases Malabsorption Syndromes Enteritis Sprue, Tropical HIV Enteropathy Crohn Disease Ileal Diseases Gastrointestinal Diseases Digestive System Diseases Metabolic Diseases Gastroenteritis |
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 |