Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT01363167
Status:
COMPLETED
Last Update Posted:
2014-11-24
First Post:
2011-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Identifying Vitamin D Deficiency in Very Low Birth Weight Infant (VLBW) Infants Part 2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-21', 'studyFirstSubmitDate': '2011-04-18', 'studyFirstSubmitQcDate': '2011-05-31', 'lastUpdatePostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intestinal Calcium Absorption', 'timeFrame': 'When receiving at least 50% of nutrition enterally expected to occur at 2-6 weeks post-birth'}, {'measure': 'Parathyroid hormone concentration', 'timeFrame': 'At term age (expected 2-4 months)'}, {'measure': 'Serum 25 hydroxyvitamin D status', 'timeFrame': 'At term age (expected 2-4 months)'}, {'measure': 'Bone Health', 'timeFrame': 'At term age (expected 2-4 months)', 'description': 'Bone ultrasound measurement, serum alkaline phosphatase, and bone-specific alkaline phosphatase at birth and monthly until term age. Bone mineralization by DEXA scan at hospital discharge and term age.'}, {'measure': 'Serum inflammatory cytokine concentrations', 'timeFrame': 'At birth (day 1)'}], 'secondaryOutcomes': [{'measure': 'Phosphorus Homeostasis', 'timeFrame': 'At term age (expected 2-4 months)', 'description': 'Measurement of serum and urine phosphorus concentrations'}, {'measure': 'Growth parameters', 'timeFrame': 'At term age (expected 2-4 months)'}, {'measure': 'Vitamin D Dose Safety as Measured by Urinary Calcium Excretion', 'timeFrame': 'At term age (expected 2-4 months)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['vitamin D', 'preterm infants', 'calcium', 'bone', 'parathyroid hormone'], 'conditions': ['Infant, Very Low Birth Weight', 'Calcium Deficiency', 'Vitamin D Deficiency']}, 'descriptionModule': {'briefSummary': 'This study is to determine the amount of vitamin D required for a very low birth weight infant to reach vitamin D sufficiency and achieve optimal calcium health and bone growth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Days', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any infant born at the Medical University of South Carolina \\<34 weeks gestation\n* Less that 1500g at birth\n* AGA\n* Must be African American or Caucasian\n* Each infant born of twin and triplet pregnancies will be eligible\n\nExclusion Criteria:\n\n* Infants with major congenital anomalies or with hemolytic disease requiring exchange transfusion\n* Infants born small for-gestational-age (SGA) or large for-gestational-age (LGA)\n* Maternal uncontrolled thyroid disease\n* Maternal Parathyroid disease\n* Infants of races other than African American or Caucasian'}, 'identificationModule': {'nctId': 'NCT01363167', 'briefTitle': 'Identifying Vitamin D Deficiency in Very Low Birth Weight Infant (VLBW) Infants Part 2', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': 'Identifying Vit D Deficiency in VLBW Infants Part 2', 'orgStudyIdInfo': {'id': 'HR# 17217'}, 'secondaryIdInfos': [{'id': 'K23RR021891', 'link': 'https://reporter.nih.gov/quickSearch/K23RR021891', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '400 IU Cholecalciferol - Vitamin D', 'interventionNames': ['Dietary Supplement: 400 IU Cholecalciferol- Vitamin D Daily']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo contains Fractionated Coconut Oil', 'interventionNames': ['Dietary Supplement: 400 IU Cholecalciferol- Vitamin D Daily']}], 'interventions': [{'name': '400 IU Cholecalciferol- Vitamin D Daily', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Infants who are defined as vitamin D deficient at birth will be randomized to receive either 400 IU vitamin D/day or placebo daily until term age is reached.', 'armGroupLabels': ['400 IU Cholecalciferol - Vitamin D', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425-8750', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Sarah N. Taylor, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Pediatrics, Medical University of SC', 'investigatorFullName': 'Sarah N Taylor', 'investigatorAffiliation': 'Medical University of South Carolina'}}}}