Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-01-04 @ 4:15 AM
Study NCT ID:
NCT02095392
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2014-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Soluble Phosphate in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005419', 'term': 'Flavonoids'}], 'ancestors': [{'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-30', 'studyFirstSubmitDate': '2014-03-17', 'studyFirstSubmitQcDate': '2014-03-20', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting phosphate concentration in blood', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Calcium and phosphorus metabolism', 'timeFrame': '8 weeks', 'description': '* parameters of phosphate and calcium metabolism (1,25-OHD; 25-OHD;FGF23;PTH)\n* parameters of bone formation and resorption (osteocalcin, P1NP, CTX)\n* minerals in plasma, faeces and urine'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['soluble phosphate', 'phosphorus metabolism', 'calcium metabolism', 'bone metabolism', 'human study'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '29452584', 'type': 'DERIVED', 'citation': 'Trautvetter U, Camarinha-Silva A, Jahreis G, Lorkowski S, Glei M. High phosphorus intake and gut-related parameters - results of a randomized placebo-controlled human intervention study. Nutr J. 2018 Feb 16;17(1):23. doi: 10.1186/s12937-018-0331-4.'}, {'pmid': '26786148', 'type': 'DERIVED', 'citation': 'Trautvetter U, Jahreis G, Kiehntopf M, Glei M. Consequences of a high phosphorus intake on mineral metabolism and bone remodeling in dependence of calcium intake in healthy subjects - a randomized placebo-controlled human intervention study. Nutr J. 2016 Jan 19;15:7. doi: 10.1186/s12937-016-0125-5.'}]}, 'descriptionModule': {'briefSummary': 'The study was conducted to investigate the effect of soluble phosphate in combination with different calcium doses on calcium and phosphorus metabolism and further physiological parameters in healthy subjects. The main aim of the study is to investigate the influence of a soluble phosphate supplementation on the fasting blood phosphate concentration and the dependency of an additional calcium intake.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18-60 years\n* physical health\n\nExclusion Criteria:\n\n* postmenopausal women\n* kidney diseases\n* diabetes mellitus\n* metabolic diseases\n* osteoporosis\n* intake of dietary supplements\n* pregnancy and lactation'}, 'identificationModule': {'nctId': 'NCT02095392', 'briefTitle': 'Effects of Soluble Phosphate in Humans', 'organization': {'class': 'OTHER', 'fullName': 'University of Jena'}, 'officialTitle': 'The Effect of Soluble Phosphate in Combination With Different Calcium Doses on Calcium and Phosphorus Metabolism in Healthy Adults', 'orgStudyIdInfo': {'id': 'H55-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'P1000/Ca0', 'interventionNames': ['Dietary Supplement: P1000/Ca0', 'Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'P1000/Ca500', 'interventionNames': ['Dietary Supplement: P1000/Ca500', 'Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'P1000/Ca1000', 'interventionNames': ['Dietary Supplement: P1000/Ca1000', 'Dietary Supplement: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: P1000/Ca0', 'Dietary Supplement: P1000/Ca500', 'Dietary Supplement: P1000/Ca1000']}], 'interventions': [{'name': 'P1000/Ca0', 'type': 'DIETARY_SUPPLEMENT', 'description': '22 subjects consume for 8 weeks a beverage enriched with phosphate \\[1g phosphorus/d\\]', 'armGroupLabels': ['P1000/Ca0', 'Placebo']}, {'name': 'P1000/Ca500', 'type': 'DIETARY_SUPPLEMENT', 'description': '22 subjects consume for 8 weeks a beverage enriched with phosphate \\[1 g phosphorus/d\\] and calcium \\[0,5 g calcium\\]', 'armGroupLabels': ['P1000/Ca500', 'Placebo']}, {'name': 'P1000/Ca1000', 'type': 'DIETARY_SUPPLEMENT', 'description': '22 subjects consume for 8 weeks a beverage enriched with phosphate \\[1 g phosphorus/d\\] and calcium \\[1 g calcium\\]', 'armGroupLabels': ['P1000/Ca1000', 'Placebo']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'all participants consume two weeks before intervention the beverage without phosphate and calcium', 'armGroupLabels': ['P1000/Ca0', 'P1000/Ca1000', 'P1000/Ca500']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07743', 'city': 'Jena', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Toxicology', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}], 'overallOfficials': [{'name': 'Michael Glei, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Toxicology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jena', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Prof. Dr. Michael Glei', 'investigatorAffiliation': 'University of Jena'}}}}