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Main
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Note: This record shows only 22 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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16 December 2017 |
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Main ID: |
NCT02084550 |
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Date of registration:
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05/03/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis
AMINOPOUCH |
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Scientific title:
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Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis: a Randomized, Assessor-blinded, Placebo-controlled Trial |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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8 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02084550 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Denmark
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Contacts
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Name:
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Søren Laurberg, MD, DMSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Surgery P, Aarhus University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with ulcerative colitis who are having an ileal pouch-anal anastomosis
performed, 18 < age < 50, written informed consent.
Exclusion Criteria:
- Inability to understand written Danish, postmenopause, severe asthma, diabetes
mellitus, severe rheumatologic disease, severe comorbidity (ASA group III-IV) in
general. Acute or progressing liver failure, uremia without possibility for dialysis,
phenylketonuria, defects in amino acid metabolism. Participation in scientific studies
in the preceding year, where ionizing radiation has been used, including significant
x-ray investigations.
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Dietary Supplement: Vaminolac
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Other: Saline
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Primary Outcome(s)
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Phenylalanine kinetics
[Time Frame: 6 hours]
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Tyrosine kinetics
[Time Frame: 6 hours]
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Palmitate balance
[Time Frame: 5 hours]
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Secondary Outcome(s)
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Plasma changes in hormones and energy sources
[Time Frame: 6 hours]
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Secondary ID(s)
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1-10-72-48-14
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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