Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-04-23 @ 10:24 PM
Study NCT ID:
NCT02812134
Status:
UNKNOWN
Last Update Posted:
2018-08-21
First Post:
2016-06-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Oral Phosphorus Supplements on the 6-month Change in FGF23 Levels in Anorexic Adolescents Suffering From Undernutrition.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D000855', 'term': 'Anorexia'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-20', 'studyFirstSubmitDate': '2016-06-16', 'studyFirstSubmitQcDate': '2016-06-21', 'lastUpdatePostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FGF23', 'timeFrame': 'at inclusion and then once a month for 6 months.', 'description': 'Change in the FGF23 level (U/ml) with regard to the exogenous phosphorus intake (doses of Phosphoneuros®, expressed in mg/kg/day)'}]}, 'conditionsModule': {'keywords': ['phosphorus supplementation', 'FGF23', 'anorexic', 'adolescents', 'undernutrition'], 'conditions': ['Malnutrition']}, 'descriptionModule': {'briefSummary': 'Fibroblast growth factor 23 (FGF23) is a recently discovered phosphaturic hormone produced by osteocytes. It is involved in phosphate-calcium metabolism (via its phosphaturic action and inhibition of 1,25-OH vitamin D).\n\nThere are no published studies on the role of FGF23 in undernourished anorexic adolescents taking oral phosphorus supplements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '11 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'anorexic patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescents aged from 11 to 17\n* Follow-up or hospitalisation for anorexia\n* Overt undernutrition (clinical signs of undernutrition, body mass index and the Waterlow index)\n* Social security coverage\n\nExclusion Criteria:\n\n* Known pre-existing renal disorders\n* Known constitutional disorders of phosphate-calcium metabolism\n* Adult patients, legal guardianship, incarceration'}, 'identificationModule': {'nctId': 'NCT02812134', 'acronym': 'IPSAASU', 'briefTitle': 'Impact of Oral Phosphorus Supplements on the 6-month Change in FGF23 Levels in Anorexic Adolescents Suffering From Undernutrition.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Impact of Oral Phosphorus Supplements on the 6-month Change in FGF23 Levels in Anorexic Adolescents Suffering From Undernutrition.', 'orgStudyIdInfo': {'id': 'PI2015_843_0006'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'anorexic'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lydia LICHTENBERGER, PhD', 'role': 'CONTACT', 'email': 'lichtenberger.lydia@chu-amiens.fr', 'phone': '+33 3 22 08 76 60'}], 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Lydia LICHTENBERGER, PhD', 'role': 'CONTACT', 'email': 'lichtenberger.lydia@chu-amiens.fr', 'phone': '+33 3 22 08 76 60'}], 'overallOfficials': [{'name': 'Lydia LICHTENBERGER, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Amiens'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}