Nutrition Support in Pediatric Stem Cell Transplantation

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Christopher Duggan, Children's Hospital Boston

ClinicalTrials.gov Identifier:

NCT00115258

First received: June 21, 2005

Last updated: February 12, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

June 21, 2005

Last Updated Date

February 12, 2013

Start Date ^ICMJE

January 2004

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Changes in % body fat at baseline, day +30, and day +100. [ Time Frame: day 30 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Changes in % body fat at baseline, day +30, and day +100.

Change History

Complete list of historical versions of study NCT00115258 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Body composition measured by DXA, BIA, and 4-site skinfolds. [ Time Frame: baseline, day 30, and day 100 ] [ Designated as safety issue: No ]
Changes in body composition from baseline to day +100. [ Time Frame: day 100 ] [ Designated as safety issue: No ]
Insulin resistance, defined by HOMA, at each time point. [ Time Frame: baseline, day 30, and day 100 ] [ Designated as safety issue: No ]
Measured resting energy expenditure (REE) at each time point. [ Time Frame: baseline, day 30, and day 100 ] [ Designated as safety issue: No ]
Changes in percent predicted REE between the two groups. [ Time Frame: baseline, day 30, and day 100 ] [ Designated as safety issue: No ]
Correlation between body composition and measured REE. [ Time Frame: baseline, day 30, and day 100 ] [ Designated as safety issue: No ]
Resumption of oral intake. [ Time Frame: day 30 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Body composition measured by DXA, BIA, and 4-site skinfolds.
Changes in body composition from baseline to day +100.
Insulin resistance, defined by HOMA, at each time point.
Measured resting energy expenditure (REE) at each time point.
Changes in percent predicted REE between the two groups.
Correlation between body composition and measured REE.
Resumption of oral intake.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Nutrition Support in Pediatric Stem Cell Transplantation

Official Title ^ICMJE

Nutrition Support in Pediatric Stem Cell Transplantation - A Randomized, Controlled Trial

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Hematopoietic Stem Cell Transplantation

Intervention ^ICMJE

Other: parenteral nutrition titrated to measured REE

Study Arm (s)

Experimental: parenteral nutrition titrated to measured REE
parenteral nutrition titrated to measured REE

Intervention: Other: parenteral nutrition titrated to measured REE
No Intervention: standard of care

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2009

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

First myeloablative allogeneic SCT using either TBI (1400 cGy) or busulfan in addition to other chemotherapeutic agents
GVHD prophylaxis with a calcineurin-inhibitor and methotrexate +/- corticosteroids
Matched, related or 6/6 HLA-matched unrelated SCT donor
Age 6 years and older

Exclusion Criteria:

Age less than 6 years, or otherwise unable to comply with study procedures
Underweight (body mass index (BMI) z-score <2 for age and sex) at baseline
Overweight (BMI z-score >2 for age and sex) at baseline
Unable or unwilling to return for day + 100 studies
Previous stem cell transplant
Unmatched SCT donor
Current treatment for hypo- or hyperthyroidism
Current insulin dependent diabetes
Current use of parenteral nutrition
Allergy to egg or soy products
Other contraindication to parenteral nutrition at baseline

Gender

Both

Ages

6 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00115258

Other Study ID Numbers ^ICMJE

86483, 03-11-192

Has Data Monitoring Committee

Responsible Party

Christopher Duggan, Children's Hospital Boston

Study Sponsor ^ICMJE

Children's Hospital Boston

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Christopher P. Duggan, M.D., M.P.H.

Children's Hospital Boston

Information Provided By

Children's Hospital Boston

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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