Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2026-01-29 @ 4:15 AM
Study NCT ID:
NCT01469650
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2011-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Serum 25-hydroxy Vitamin D [25(OH)D] Levels, Supplemental Vitamin D, and Parathyroid Hormone Levels in Premature Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-01', 'studyFirstSubmitDate': '2011-11-08', 'studyFirstSubmitQcDate': '2011-11-09', 'lastUpdatePostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum 25-hydroxy vitamin D [25(OH)D] Levels', 'timeFrame': '1 year', 'description': 'Serum 25-hydroxy vitamin D \\[25(OH)D\\] levels will be compared between the two groups, vitamin D supplementation of 400 IU vitamin D3/day, or 800 IU vitamin D3/day. The specific aims of this study are to determine leves of vitamin D supplementation to achieve goal serum 25(OH)D levels of 30 ng/mL.'}], 'secondaryOutcomes': [{'measure': 'Parathyroid Hormone Levels', 'timeFrame': '1 year', 'description': 'Parathyroid hormone levels will be compared in between the two groups, vitamin D supplementation of 400 IU vitamin D3/day, or 800 IU vitamin D3/day.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vitamin D3', 'prematurity', 'parathyroid hormone', '25(OH)D', 'NICU hospitalization'], 'conditions': ['Premature Infants']}, 'referencesModule': {'references': [{'pmid': '33305842', 'type': 'DERIVED', 'citation': 'Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine levels of vitamin D supplementation to achieve goal serum 25-hydroxy vitamin D \\[25(OH)D\\] levels of 30 ng/mL, and to define serum 25(OH)D levels required to achieve suppression of parathyroid hormone in preterm newborn infants hospitalized in Newborn Intensive Care Nursery (NICU). Infants 23 weeks gestational age or greater will be randomized to two different levels of vitamin D supplementation: 400 IU vitamin D3/day, or 800 IU vitamin D3/day.', 'detailedDescription': 'The specific aims of this study are to determine levels of vitamin D supplementation to achieve goal serum 25(OH)D levels of 30 ng/mL, and to define serum 25(OH)D levels required to achieve suppression of parathyroid hormone in preterm newborn infants hospitalized in the Nebraska Medical Center Newborn Intensive Care Nursery (NICU). In this randomized, controlled trial, infants 23 weeks gestational age or greater will be randomized to two different levels of vitamin D supplementation: 400 IU vitamin D3/day, or 800 IU vitamin D3/day. As an exploratory aim, vitamin D binding protein levels (VDBP) will also be quantified in these infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '32 Weeks', 'minimumAge': '23 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NICU hospitalized infants\n* 23-32 weeks gestation\n\nExclusion Criteria:\n\n* congential anomalies\n* disorders of calcium metabolism\n* inborn error of metabolism\n* kidney disease\n* liver disease\n* use of steroids'}, 'identificationModule': {'nctId': 'NCT01469650', 'briefTitle': 'Serum 25-hydroxy Vitamin D [25(OH)D] Levels, Supplemental Vitamin D, and Parathyroid Hormone Levels in Premature Infants', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Serum 25-hydroxy Vitamin D [25(OH)D] Levels, Supplemental Vitamin D, and Parathyroid Hormone Levels in Premature Infants', 'orgStudyIdInfo': {'id': '0419-11-FB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '400 IU/day vitamin D', 'description': 'Subjects will receive 400 IU/day of vitamin D3, as per current unit policy', 'interventionNames': ['Dietary Supplement: cholecalciferal']}, {'type': 'EXPERIMENTAL', 'label': '800 IU/day vitamin D3', 'description': 'Subjects will receive 800 IU/day vitamin D3', 'interventionNames': ['Dietary Supplement: cholecalciferol']}], 'interventions': [{'name': 'cholecalciferal', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['vitamin D3'], 'description': '400 IU/day', 'armGroupLabels': ['400 IU/day vitamin D']}, {'name': 'cholecalciferol', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['vitamin D3'], 'description': '800 IU/day D3', 'armGroupLabels': ['800 IU/day vitamin D3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Unversity of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Corrine K Hanson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}