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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01386034 |
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Date of registration:
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24/06/2011 |
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Primary sponsor: |
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Public title:
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Effects of Oral Citrulline on Protein Metabolism in Patients With Intestinal Failure (Citrugrêle 2)
CITRUGRELE 2 |
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Scientific title:
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Effects of Oral Citrulline on Protein Metabolism in Patients With Intestinal Failure : a Prospective, Randomized, Double-blind, Cross-over Study |
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Date of first enrolment:
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June 2012 |
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Target sample size:
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12 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01386034 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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France
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Contacts
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Name:
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Dominique DARMAUN, Pr |
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Address:
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Telephone:
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+33 2 40 08 42 75 |
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Email:
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dominique.darmaun@chu-nantes.fr |
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Affiliation:
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Name:
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Dominique DARMAUN, Pr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Nantes University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult between 18 and 75 years
- Patient with short bowel syndrome
- Patient with an incompetent small intestine after intestinal resection
- Patient fed orally and beyond more than 6 weeks after surgery
- Absence of any earlier supplementation with citrulline, glutamine, ornithine
a-ketoglutarate, or stimol®
- No current artificial feeding (parenteral)
- No low-sodium diet- No renal, cardiac, respiratory or hepatic insufficiency
- No chronic inflammatory disease (intestinal or other)
- No current corticosteroid treatment
- Fasting blood glucose below 6mmol/L
- Patient able to understand benefits and risks of protocol
- Women who are of childbearing potential must have a negative serum pregnancy test and
agree to use a medically acceptable method of contraception throughout the study and
for 15 days following the end of the study
- Signed informed consent
Exclusion Criteria:
- Subject not fulfilling inclusion criteria
- Subject mentioned in articles L1121-5 to L1121-8 of "code de la santé publique"
- Pregnancy
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Intestinal Failure
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Intervention(s)
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Drug: Citrulline and placebo
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Primary Outcome(s)
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whole body protein synthesis
[Time Frame: No]
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Secondary Outcome(s)
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Measure of insulin
[Time Frame: No]
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Measure of insulin-like-growth factor 1 (IGF-1)
[Time Frame: No]
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nitrogen balance
[Time Frame: No]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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