Nutrition Support in Pediatric Stem Cell Transplantation

February 12, 2013 updated by: Christopher Duggan, Boston Children's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: standard of care
Experimental: parenteral nutrition titrated to measured REE
Other: parenteral nutrition titrated to measured REE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in % body fat at baseline, day +30, and day +100.
Time Frame: day 30
day 30

Secondary Outcome Measures

Outcome Measure
Time Frame
Body composition measured by DXA, BIA, and 4-site skinfolds.
Time Frame: baseline, day 30, and day 100
baseline, day 30, and day 100
Changes in body composition from baseline to day +100.
Time Frame: day 100
day 100
Insulin resistance, defined by HOMA, at each time point.
Time Frame: baseline, day 30, and day 100
baseline, day 30, and day 100
Measured resting energy expenditure (REE) at each time point.
Time Frame: baseline, day 30, and day 100
baseline, day 30, and day 100
Changes in percent predicted REE between the two groups.
Time Frame: baseline, day 30, and day 100
baseline, day 30, and day 100
Correlation between body composition and measured REE.
Time Frame: baseline, day 30, and day 100
baseline, day 30, and day 100
Resumption of oral intake.
Time Frame: day 30
day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Children's Hospital

Investigators

  • Principal Investigator: Christopher P. Duggan, M.D., M.P.H., Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

June 21, 2005

First Submitted That Met QC Criteria

June 21, 2005

First Posted (Estimate)

June 22, 2005

Study Record Updates

Last Update Posted (Estimate)

February 13, 2013

Last Update Submitted That Met QC Criteria

February 12, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 86483
  • 03-11-192

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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