Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2026-01-04 @ 12:16 PM
Study NCT ID:
NCT07231666
Status:
COMPLETED
Last Update Posted:
2025-11-17
First Post:
2022-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimised Osmolality in Oral Supplements Optimised Osmolality in Oral Supplements
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000090124', 'term': 'Intestinal Failure'}, {'id': 'D003681', 'term': 'Dehydration'}], 'ancestors': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014867', 'term': 'Water'}, {'id': 'D018752', 'term': 'Diet, Fat-Restricted'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The patients were randomised to receive either the hypo-osmolar or hyper-osmolar in their first intervention. Microsoft Excel feature "RAND" (Microsoft version 16) was used to randomize oral supplements. Each supplement was assigned a number. Every time a patient agreed to one or two more intervention periods, two supplements were randomized. One of the primary investigators (JQ) enrolled and randomized supplements to the patients'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This was a single-centre, quasi-randomised cross-over intervention study. The effects of osmolality in oral supplements were investigated using a 3x3 cross-over design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2022-08-01', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ileostomy output', 'timeFrame': '6 hours', 'description': 'ileostomy output (wet weight feces grams)'}], 'secondaryOutcomes': [{'measure': 'natriuresis', 'timeFrame': '6 hours', 'description': 'urine volume (mL)'}, {'measure': 'urine sodium', 'timeFrame': '6 hours', 'description': 'urine sodium mmol'}, {'measure': 'urine osmolality', 'timeFrame': '6 hours', 'description': 'urine osmolality (mmol/kg)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ileostomy', 'osmolality', 'natriuresis', 'dehydration', 'electrolyte'], 'conditions': ['Ileostomy - Stoma', 'Intestinal Failure']}, 'referencesModule': {'references': [{'pmid': '38777478', 'type': 'RESULT', 'citation': 'Quist JR, Rud CL, Frumer K, Julsgaard M, Dahl Baunwall SM, Hvas CL. Osmolality in oral supplements drives ileostomy output: Defining the Goldilocks zone. Clin Nutr ESPEN. 2024 Jun;61:88-93. doi: 10.1016/j.clnesp.2024.03.003. Epub 2024 Mar 15.'}]}, 'descriptionModule': {'briefSummary': 'Quasi-randomized, crossover intervention study, testing osmolality in oral drinks and effect on 6-hours ileostomy output in adult patients with an ileostomy', 'detailedDescription': '14 patients with ileostomies were included in a quasi-randomized, crossover intervention study. Each patient ingested between 3-18 different supplements during separate 6-hours intervention periods. Ileostomy output and urine volume will be collected. Outcome measures include faecal wet-weight, urine volume, electrolytes, osmolality, and body composition measured with bioelectrical impedance analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age 18 years or higher\n2. ileostomy formed at least 8 weeks before enrolment\n3. consent to participate\n\nExclusion Criteria:\n\n1. pregnancy\n2. known chronic kidney disease\n3. known diabetes mellitus\n4. too long driving distance\n5. parenteral nutrition/fluid more than 6 litres per month'}, 'identificationModule': {'nctId': 'NCT07231666', 'acronym': 'Goldilocks', 'briefTitle': 'Optimised Osmolality in Oral Supplements Optimised Osmolality in Oral Supplements', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': "Goldilocks' Zone: Optimised Osmolality in Supplements for the Patient With an Ileostomy", 'orgStudyIdInfo': {'id': '1-10-72-289-21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'hypoosmolar', 'description': 'One with a hypo-osmolar fluid', 'interventionNames': ['Dietary Supplement: water']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'isoosmolar', 'description': 'one with an iso-osmolar fluid', 'interventionNames': ['Dietary Supplement: semi skimmed milk or powerade']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'hyperosmolar', 'description': 'one with a hyper-osmolar', 'interventionNames': ['Dietary Supplement: juice']}], 'interventions': [{'name': 'water', 'type': 'DIETARY_SUPPLEMENT', 'description': 'oral commercially available supplements', 'armGroupLabels': ['hypoosmolar']}, {'name': 'semi skimmed milk or powerade', 'type': 'DIETARY_SUPPLEMENT', 'description': 'oral commercially available supplements', 'armGroupLabels': ['isoosmolar']}, {'name': 'juice', 'type': 'DIETARY_SUPPLEMENT', 'description': 'oral commercially available supplements', 'armGroupLabels': ['hyperosmolar']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus C', 'country': 'Denmark', 'facility': 'Department of medicine V (Hepatology and Gastroenterology)', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}, {'zip': '8200', 'city': 'Aarhus N', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}