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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
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This double-blinded, active comparator, cross-over intervention study tested the impact of two different oral supplements on ileostomy output volume and urinary sodium excretion and intestinal aquaporin expression in eight compensated patients with an ileostomy and not on home parenteral Nutrition or fluid support.
Patients with an ileostomy may experience fluid and electrolyte imbalances sedondary to an unregulated intestinal loss of water and electrolytes. The osmolality of oral supplements may affect these losses. In a double-blinded, active comparator, cross-over intervention study, the investigators test the effects of substituting 800 ml of the usual fluid intake with an intake of either an isoosmolar (300 mOsm/kg) or hyperosmolar (700 mOsm/kg) supplement during 48 hours, following baseline data collection before both intervention periods. Outcome measures were stoma output volume, 24-hour urine and urinary sodium excretion, and intestinal aquaporin 3 and 8 expressions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Isoosmolar | Experimental | Iso-osmolar oral supplement (276 mOsm/kg) |
|
| Hyperosmolar | Active Comparator | Hyper-osmolar oral supplement (681 mOsm/kg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isoosmolar | Dietary Supplement | 48 hours, 800 ml per 24 hours |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Stoma output | 24 hour stoma output weight | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour urine production | 24 hour urine volume (ml) | 24 hours |
| 24-hour urinary sodium excretion | 24-hour sodium (mmol) | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hendrik Vilstrup, Professor | University of Aarhus | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus C | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30396772 | Derived | Rud C, Pedersen AKN, Wilkens TL, Borre M, Andersen JR, Moeller HB, Dahlerup JF, Hvas CL. An iso-osmolar oral supplement increases natriuresis and does not increase stomal output in patients with an ileostomy: A randomised, double-blinded, active comparator, crossover intervention study. Clin Nutr. 2019 Oct;38(5):2079-2086. doi: 10.1016/j.clnu.2018.10.014. Epub 2018 Oct 24. |
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Publication of anonymised data. Data backup in accessible data platform.
During last 6 months of study period, 10 years
established researcher
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| ID | Term |
|---|---|
| D012778 | Short Bowel Syndrome |
| D007010 | Hyponatremia |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Double-blinded, active comparator, cross-over intervention study
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Randomisation by Third party; Unblinded study nurse to mix and deliver study product; masking of product to ensure comparable palatability and appearance; blinding to analyses
| Hyperosmolar |
| Dietary Supplement |
48 hours, 800 ml per 24 hours |
|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009748 | Nutrition Disorders |