Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-02-25 @ 11:03 PM
Study NCT ID:
NCT03618394
Status:
COMPLETED
Last Update Posted:
2018-08-07
First Post:
2018-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone Turnover and Parenteral Nutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-04', 'studyFirstSubmitDate': '2018-07-25', 'studyFirstSubmitQcDate': '2018-08-04', 'lastUpdatePostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in plasma calcium and osteocalcin levels', 'timeFrame': '20 days', 'description': 'Blood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life'}], 'secondaryOutcomes': [{'measure': 'change in plasma DHA, EPA levels', 'timeFrame': '20 days', 'description': 'Blood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life'}, {'measure': 'cange in plasma OPG levels', 'timeFrame': '20 days', 'description': 'Blood sample at 1st or 2nd (within 48 hours of birth) and 20th day of life'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preterms', 'parenteral', 'lipid'], 'conditions': ['Bone Turnover Rate Disorder']}, 'descriptionModule': {'briefSummary': 'Evaluation of changes in biochemical markers of bone metabolism. Fat profile. Evaluation of the overall body development. Assessment of parenteral nutrition protocols.', 'detailedDescription': 'Osteopenia is very common in premature infants, particularly in preterm infants born at extremely low birth weight This is probably related to inadequate calcium and phosphorus intake, which is considerably less than the accretion of these minerals during the last trimester of pregnancy In addition, severe morbidity during the neonatal period (e.g. bronchopulmonary dysplasia \\[BPD\\]), chronic drug therapy (e.g. diuretics and systemic steroids), the need for total parenteral nutrition and prolonged immobility increase the risk of bone demineralization.\n\nTotal parenteral nutrition is associated with osteopenia in preterm infants. Insufficient calcium and phosphate are likely causes; aluminum contamination is another possible contributing factor as this adversely affects bone formation and mineralization.\n\nThe DHA+ARA-supplemented formulas supported normal growth and bone mineralization in premature infants who were born at \\<33 wk gestation. Smof lipid emulsion has a high density of this fatty acids, while Intra lipid does not contain any traces of DHA. Evidence has shown that long-chain polyunsaturated fatty acids (LCPUFA), especially the ω-3 fatty acids such as eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are beneficial for bone health and turnover.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Days', 'minimumAge': '1 Day', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Very Low Birth Weight preterm neonates with gestational age \\<32 weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gestational age \\<32 weeks\n* birth weight \\<1500g (VLBW infants)\n* in need of Parenteral Nutrition support\n\nExclusion Criteria:\n\n* \\>32 weeks of gestation\n* chromosomal or other abnormalities\n* parenteral nutrition \\<80% of calorie/fluid needs\n* primary liver disease'}, 'identificationModule': {'nctId': 'NCT03618394', 'briefTitle': 'Bone Turnover and Parenteral Nutrition', 'organization': {'class': 'OTHER', 'fullName': 'Iaso Maternity Hospital, Athens, Greece'}, 'officialTitle': 'Early Bone Turnover Markers in Relation to Parenteral Nutrition Regimens', 'orgStudyIdInfo': {'id': '29042015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Smoflipid', 'description': 'premature neonates receiving MCT/ω-3-PUFA-containing lipid emulsion', 'interventionNames': ['Dietary Supplement: MCT/ω-3-PUFA']}, {'label': 'Intralipid', 'description': 'premature neonates receiving Soybean Based lipid emulsion', 'interventionNames': ['Dietary Supplement: Soybean Based']}], 'interventions': [{'name': 'MCT/ω-3-PUFA', 'type': 'DIETARY_SUPPLEMENT', 'description': 'lipid emulsion', 'armGroupLabels': ['Smoflipid']}, {'name': 'Soybean Based', 'type': 'DIETARY_SUPPLEMENT', 'description': 'lipid emulsion', 'armGroupLabels': ['Intralipid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15123', 'city': 'Athens', 'country': 'Greece', 'facility': 'Panos Papandreou', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iaso Maternity Hospital, Athens, Greece', 'class': 'OTHER'}, 'collaborators': [{'name': 'Harokopio University', 'class': 'OTHER'}, {'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Pharmacist, PharmD', 'investigatorFullName': 'Panos Papandreou', 'investigatorAffiliation': 'Iaso Maternity Hospital, Athens, Greece'}}}}