Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT05777356
Status:
COMPLETED
Last Update Posted:
2023-11-28
First Post:
2023-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sanitary Napkins for Urinary Assessment of Micronutrients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059349', 'term': 'Urine Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2023-03-08', 'studyFirstSubmitQcDate': '2023-03-20', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean difference of urinary biomarkers between groups', 'timeFrame': '8-9 weeks after completion', 'description': 'Exploratory analysis of differences by dietary group in urinary iodine nomalized to creatinin.'}, {'measure': 'Mean difference of urinary biomarkers between groups', 'timeFrame': '8-9 weeks after completion', 'description': 'Exploratory analysis of differences by dietary group in methylmalonic acid nomalized to creatinin.'}], 'primaryOutcomes': [{'measure': 'Correlation untreated and expressed urine', 'timeFrame': '8-9 weeks after completion', 'description': 'Correlation of creatinine, methylmalonic acid and iodine between unprocessed urine and urine expressed from a sanitary diaper to evaluate possible matrix effects on analytes.'}], 'secondaryOutcomes': [{'measure': 'Correlation of urinary biomarkers with food and supplement intake', 'timeFrame': '8-9 weeks after completion', 'description': 'Correlation of dietary intake assessed by a food frequency questionnaire with urinary iodine and methylmalonic acid normalized to creatinine.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Focus: Nutritional Deficiency']}, 'descriptionModule': {'briefSummary': 'This study aims to find an easy urinary collection method for the assessment of urinary markers of micronutrient status.', 'detailedDescription': 'Urinary collection in newborns and infants can be difficult. Our study aims to find an easy and cheap alternative to urinary collection bags and specialized pads that can be used to measure biomarkers of iodine and vitamin B12 status in urine and can be employed in large scale trials. Using correlation analyses, the association of urinary iodine and methylmalonic acid from healthy volunteers will be assessed between untreated sample and a sample expressed from a sanitary napkin. Participants will be recruited based on their dietary pattern (omnivorous, vegetarian and vegans) to have a broad spectrum of analyte concentration. Participants weight, height, age, nutritional supplement use and diet will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants are primarily recruited at the University of Hohenheim', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy volunteers Written informed consent\n\nExclusion Criteria:\n\nBMI \\< 18,5 and \\>24,9 Use of medication (except contraceptives) Smoking'}, 'identificationModule': {'nctId': 'NCT05777356', 'briefTitle': 'Sanitary Napkins for Urinary Assessment of Micronutrients', 'organization': {'class': 'OTHER', 'fullName': 'University of Hohenheim'}, 'officialTitle': 'Pilot Study: Collection of Urine From Sanitary Napkins for the Analysis of Micronutrient Deficiencies', 'orgStudyIdInfo': {'id': 'NapUrine'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Omivorous', 'description': 'Healthy volunteers without dietary restrictions', 'interventionNames': ['Diagnostic Test: Urine collection and assessment of dietary intake by food frequency questionaire']}, {'label': 'Vegetarians', 'description': 'Healthy volunteers who do not consume meat products', 'interventionNames': ['Diagnostic Test: Urine collection and assessment of dietary intake by food frequency questionaire']}, {'label': 'Vegans', 'description': 'Healthy volunteers who do not consume any animal product', 'interventionNames': ['Diagnostic Test: Urine collection and assessment of dietary intake by food frequency questionaire']}], 'interventions': [{'name': 'Urine collection and assessment of dietary intake by food frequency questionaire', 'type': 'DIAGNOSTIC_TEST', 'description': 'urinary iodine, creatinine and methylmalonic acid, iodine and vitamin B12 dietary intake from foods and supplements', 'armGroupLabels': ['Omivorous', 'Vegans', 'Vegetarians']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70599', 'city': 'Stuttgart', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'University of Hohenheim', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Hohenheim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. rer. nat. Maren Podszun', 'investigatorFullName': 'Maren Podszun', 'investigatorAffiliation': 'University of Hohenheim'}}}}