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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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12 December 2020 |
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Main ID: |
NCT03348709 |
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Date of registration:
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16/11/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Osmolality of Oral Supplements and Ileostomy Output
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Scientific title:
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Does Osmolality of Oral Supplements Affect Stoma Output and Natriuresis in Patients With an Ileostomy? |
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Date of first enrolment:
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June 1, 2017 |
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Target sample size:
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8 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03348709 |
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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: Crossover Assignment. Primary purpose: Treatment. 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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Hendrik Vilstrup, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Aarhus |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- age 18 years or more
- ilestomy established 6 weeks or more prior to inclusion
- able to drink at least 100 ml fluid per 24 hours
- i known inflammatory bowel disease, clinical remission judged by physician's global
assessment (PGA)
- less than 5 kg self-reported weight change during the past 3 months
Exclusion Criteria:
- self-reported intolerance to dairy products, including lactose
- known renal insufficiency, defined by an eGFR less than 30 ml/min
- known diabetes mellitus, defined by an HbA1C > 48 mmol/mol (6.5%)
- current enteral tube feeding or parenteral fluid or Nutrition support more than twice
weekly
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ileostomy - Stoma
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Nutritional Deficiency
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Short Bowel Syndrome
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Sodium Depletion
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Intervention(s)
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Dietary Supplement: Hyperosmolar
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Dietary Supplement: Isoosmolar
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Primary Outcome(s)
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Stoma output
[Time Frame: 24 hours]
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Secondary Outcome(s)
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24-hour urinary sodium excretion
[Time Frame: 24 hours]
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24-hour urine production
[Time Frame: 24 hours]
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Secondary ID(s)
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1-10-72-12-17
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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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