Osmolality of Oral Supplements and Ileostomy Output

NCT03348709 | Completed

• 1 other identifier: 1-10-72-12-17
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ileostomy - Stoma; Short Bowel Syndrome; Sodium Depletion; Nutritional Deficiency

Outcome Measures

Primary Outcomes (1)

• Stoma output

  24 hour stoma output weight

  24 hours

Secondary Outcomes (2)

• 24-hour urine production

  24 hours

• 24-hour urinary sodium excretion

  24 hours

Study Arms (2)

Isoosmolar

EXPERIMENTAL

Iso-osmolar oral supplement (276 mOsm/kg)

Dietary Supplement: Isoosmolar

Hyperosmolar

ACTIVE COMPARATOR

Hyper-osmolar oral supplement (681 mOsm/kg)

Dietary Supplement: Hyperosmolar

Interventions

Isoosmolar DIETARY_SUPPLEMENT

48 hours, 800 ml per 24 hours

Isoosmolar

Hyperosmolar DIETARY_SUPPLEMENT

48 hours, 800 ml per 24 hours

Hyperosmolar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 years or more
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• University of Copenhagen: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 30396772 DERIVED

MeSH Terms

Conditions

Short Bowel Syndrome; Hyponatremia; Malnutrition

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Nutrition Disorders

Study Officials

• Hendrik Vilstrup, Professor

  University of Aarhus

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD, associate professor

Model Details: Double-blinded, active comparator, cross-over intervention study

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 21, 2017
• Study Start: June 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: November 1, 2018
• Last Updated: November 5, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: During last 6 months of study period, 10 years
• Access Criteria: established researcher

Locations

DK (1)