Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2026-01-28 @ 10:36 PM
Study NCT ID:
NCT02900261
Status:
COMPLETED
Last Update Posted:
2018-04-20
First Post:
2016-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Sodium and Caffeine in Children and Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urine samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-18', 'studyFirstSubmitDate': '2016-09-09', 'studyFirstSubmitQcDate': '2016-09-09', 'lastUpdatePostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary sodium excretion', 'timeFrame': 'Over a 2-day period', 'description': 'Measured in 24 hour urine and estimated from 3 different urinary spots'}, {'measure': 'Urinary caffeine and related metabolites excretion', 'timeFrame': 'Over a 2-day period', 'description': 'Measured in 24 hour urine and estimated by a semi-quantitative food frequency questionnaire'}], 'secondaryOutcomes': [{'measure': 'Sodium consumption', 'timeFrame': 'Over a 2-day period', 'description': 'Estimated by a semi-quantitative food frequency questionnaire'}, {'measure': 'Urinary phosphate excretion', 'timeFrame': 'Over a 2-day period', 'description': 'Measured in 24 hour urine and estimated from 3 different urinary spots'}, {'measure': 'Urinary caffeine and metabolites excretion', 'timeFrame': 'Over a 2-day period', 'description': 'Measured in 24 hour urine and estimated from 3 different urinary spots'}, {'measure': 'Urinary albumine excretion', 'timeFrame': 'Over a 2-day period', 'description': 'Measured in 24 hour urine and estimated from 3 different urinary spots'}, {'measure': 'Urinary protein excretion', 'timeFrame': 'Over a 2-day period', 'description': 'Measured in 24 hour urine and estimated from 3 different urinary spots'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sodium', 'Caffeine']}, 'referencesModule': {'references': [{'pmid': '32388721', 'type': 'DERIVED', 'citation': 'Paccaud Y, Rios-Leyvraz M, Bochud M, Tabin R, Genin B, Russo M, Rossier MF, Bovet P, Chiolero A, Parvex P. Spot urine samples to estimate 24-hour urinary calcium excretion in school-age children. Eur J Pediatr. 2020 Nov;179(11):1673-1681. doi: 10.1007/s00431-020-03662-z. Epub 2020 May 9.'}, {'pmid': '32016643', 'type': 'DERIVED', 'citation': 'Rios-Leyvraz M, Bochud M, Tabin R, Genin B, Russo M, Rossier MF, Eap CB, Bovet P, Chiolero A. Monitoring caffeine intake in children with a questionnaire and urine collection: a cross-sectional study in a convenience sample in Switzerland. Eur J Nutr. 2020 Dec;59(8):3537-3543. doi: 10.1007/s00394-020-02187-3. Epub 2020 Feb 3.'}, {'pmid': '30517722', 'type': 'DERIVED', 'citation': 'Rios-Leyvraz M, Bovet P, Tabin R, Genin B, Russo M, Rossier MF, Bochud M, Chiolero A. Urine Spot Samples Can Be Used to Estimate 24-Hour Urinary Sodium Excretion in Children. J Nutr. 2018 Dec 1;148(12):1946-1953. doi: 10.1093/jn/nxy211.'}, {'pmid': '30341681', 'type': 'DERIVED', 'citation': 'Rios-Leyvraz M, Bovet P, Bochud M, Genin B, Russo M, Rossier MF, Tabin R, Chiolero A. Estimation of salt intake and excretion in children in one region of Switzerland: a cross-sectional study. Eur J Nutr. 2019 Oct;58(7):2921-2928. doi: 10.1007/s00394-018-1845-4. Epub 2018 Oct 19.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare different methods (24 hour urine collection, evening and morning spots, and questionnaires) to measure the consumption of sodium and cafeine in children and adolescents.', 'detailedDescription': 'Sodium consumption among adults is high in Switzerland, as in most parts of the world. It is expected to be high in children as well, but little is still known. 24 hour urine collection is the golden standard to assess sodium consumption. However, this method is logistically difficult, especially for children. Therefore, alternatives are needed. Urinary spots have been used as a proxy to estimate sodium excretion over 24 hour in adults, but not in children. This study will assess whether urinary spots can be used to estimate sodium consumption in children in comparison to 24 hour urine collections.\n\nCaffeine consumption has risen in children over the past years, mainly before of the increase in consumption of soda drinks. A precise way to measure caffeine consumption is by assessing the concentration of caffeine and its metabolites in 24 hour urine samples. An alternative to 24 hour urine collection is using questionnaires, however this remains difficult due to the multiples food sources of caffeine. This study will compare caffeine consumption estimated by 24 hour urine collection and by a semi-quantitative food frequency questionnaire targeting caffeine containing products.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children between 6 and 16 years of age, following ambulatorily at the Hospital of Sion', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 6 and 16 years of age\n\nExclusion Criteria:\n\n* A sickness that affects the consumption and excretion of sodium and caffeine (for example, diabetes, cardiovascular or gastrointestinal problems, chronic kidney disease, renal insufficiency)\n* Taking medication that affects sodium excretion (for example, diuretics)\n* A intravenous perfusion during the urine collection\n* Insufficient knowledge of French to understand the instructions'}, 'identificationModule': {'nctId': 'NCT02900261', 'briefTitle': 'Study on Sodium and Caffeine in Children and Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'University of Lausanne Hospitals'}, 'officialTitle': 'Comparison of Methods to Measure the Consumption of Sodium and Caffeine in Children', 'orgStudyIdInfo': {'id': '2016-01178'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'This study is observational and does not entail any intervention. Different methods to assess sodium and caffeine consumption will be compared.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1951', 'city': 'Sion', 'state': 'Valais', 'country': 'Switzerland', 'facility': 'Hôpital du Valais', 'geoPoint': {'lat': 46.22739, 'lon': 7.35559}}], 'overallOfficials': [{'name': 'Arnaud Chiolero, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'arnaud.chiolero@chuv.ch'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The results of this study will be published in an article. The full dataset will be made available in the DATA@IUMSP repository, http://data.iumsp.ch.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lausanne Hospitals', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hôpital du Valais', 'class': 'OTHER'}, {'name': 'Federal Food Safety and Veterinary Office', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Epidemiologist & Senior lecturer', 'investigatorFullName': 'Arnaud Chiolero', 'investigatorAffiliation': 'University of Lausanne Hospitals'}}}}