Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-01-06 @ 5:25 AM
Study NCT ID:
NCT00115258
Status:
COMPLETED
Last Update Posted:
2013-02-13
First Post:
2005-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutrition Support in Pediatric Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-12', 'studyFirstSubmitDate': '2005-06-21', 'studyFirstSubmitQcDate': '2005-06-21', 'lastUpdatePostDateStruct': {'date': '2013-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in % body fat at baseline, day +30, and day +100.', 'timeFrame': 'day 30'}], 'secondaryOutcomes': [{'measure': 'Body composition measured by DXA, BIA, and 4-site skinfolds.', 'timeFrame': 'baseline, day 30, and day 100'}, {'measure': 'Changes in body composition from baseline to day +100.', 'timeFrame': 'day 100'}, {'measure': 'Insulin resistance, defined by HOMA, at each time point.', 'timeFrame': 'baseline, day 30, and day 100'}, {'measure': 'Measured resting energy expenditure (REE) at each time point.', 'timeFrame': 'baseline, day 30, and day 100'}, {'measure': 'Changes in percent predicted REE between the two groups.', 'timeFrame': 'baseline, day 30, and day 100'}, {'measure': 'Correlation between body composition and measured REE.', 'timeFrame': 'baseline, day 30, and day 100'}, {'measure': 'Resumption of oral intake.', 'timeFrame': 'day 30'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nutrition, Parenteral', 'Body Composition', 'Energy Expenditure'], 'conditions': ['Hematopoietic Stem Cell Transplantation']}, 'referencesModule': {'references': [{'pmid': '12816778', 'type': 'BACKGROUND', 'citation': "Duggan C, Bechard L, Donovan K, Vangel M, O'Leary A, Holmes C, Lehmann L, Guinan E. Changes in resting energy expenditure among children undergoing allogeneic stem cell transplantation. Am J Clin Nutr. 2003 Jul;78(1):104-9. doi: 10.1093/ajcn/78.1.104."}, {'pmid': '20004739', 'type': 'BACKGROUND', 'citation': 'Bechard LJ, Feldman HA, Gordon C, Gura K, Sonis A, Leung K, Venick R, Guinan EC, Duggan C. A multi-center, randomized, controlled trial of parenteral nutrition titrated to resting energy expenditure in children undergoing hematopoietic stem cell transplantation ("PNTREE"): rationale and design. Contemp Clin Trials. 2010 Mar;31(2):157-64. doi: 10.1016/j.cct.2009.12.002. Epub 2010 Jan 3.'}, {'pmid': '22205317', 'type': 'RESULT', 'citation': 'Sharma TS, Bechard LJ, Feldman HA, Venick R, Gura K, Gordon CM, Sonis A, Guinan EC, Duggan C. Effect of titrated parenteral nutrition on body composition after allogeneic hematopoietic stem cell transplantation in children: a double-blind, randomized, multicenter trial. Am J Clin Nutr. 2012 Feb;95(2):342-51. doi: 10.3945/ajcn.111.026005. Epub 2011 Dec 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine which method of providing parenteral nutrition (complete intravenous nutrition) will provide the best nutritional and clinical results to children undergoing hematopoietic stem cell transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First myeloablative allogeneic SCT using either TBI (1400 cGy) or busulfan in addition to other chemotherapeutic agents\n* GVHD prophylaxis with a calcineurin-inhibitor and methotrexate +/- corticosteroids\n* Matched, related or 6/6 HLA-matched unrelated SCT donor\n* Age 6 years and older\n\nExclusion Criteria:\n\n* Age less than 6 years, or otherwise unable to comply with study procedures\n* Underweight (body mass index (BMI) z-score \\<2 for age and sex) at baseline\n* Overweight (BMI z-score \\>2 for age and sex) at baseline\n* Unable or unwilling to return for day + 100 studies\n* Previous stem cell transplant\n* Unmatched SCT donor\n* Current treatment for hypo- or hyperthyroidism\n* Current insulin dependent diabetes\n* Current use of parenteral nutrition\n* Allergy to egg or soy products\n* Other contraindication to parenteral nutrition at baseline'}, 'identificationModule': {'nctId': 'NCT00115258', 'briefTitle': 'Nutrition Support in Pediatric Stem Cell Transplantation', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Nutrition Support in Pediatric Stem Cell Transplantation - A Randomized, Controlled Trial', 'orgStudyIdInfo': {'id': '86483'}, 'secondaryIdInfos': [{'id': '03-11-192'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'parenteral nutrition titrated to measured REE', 'description': 'parenteral nutrition titrated to measured REE', 'interventionNames': ['Other: parenteral nutrition titrated to measured REE']}, {'type': 'NO_INTERVENTION', 'label': 'standard of care'}], 'interventions': [{'name': 'parenteral nutrition titrated to measured REE', 'type': 'OTHER', 'armGroupLabels': ['parenteral nutrition titrated to measured REE']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Christopher P. Duggan, M.D., M.P.H.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor of pediatrics', 'investigatorFullName': 'Christopher Duggan', 'investigatorAffiliation': "Boston Children's Hospital"}}}}