Nutrition Support in Pediatric Stem Cell Transplantation

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00115258

Enrollment

Registered

2005-06-22

Start date

2004-01-31

Completion date

2009-07-31

Last updated

2013-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic Stem Cell Transplantation

Keywords

Nutrition, Parenteral, Body Composition, Energy Expenditure

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.

Interventions

OTHERparenteral nutrition titrated to measured REE

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026