This 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.

Condition	Intervention	Phase
Hematopoietic Stem Cell Transplantation	Drug: Parenteral Nutrition	Phase III

Further Study Details: 

Primary Outcomes: Changes in % body fat at baseline, day +30, and day +100.
Secondary Outcomes: 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.
Expected Total Enrollment:  48

Ages Eligible for Study:  6 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00115258

Lori J Bechard, M.Ed., R.D.      617-355-5293    lori.bechard@childrens.harvard.edu
Christopher P. Duggan, M.D., M.P.H.      617-355-7612    christopher.duggan@childrens.harvard.edu

Massachusetts
      Children''''s Hospital Boston, Boston,  Massachusetts,  02115,  United States; Recruiting

Study chairs or principal investigators

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

Study ID Numbers:  86483; 03-11-192
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 21, 2005
ClinicalTrials.gov Identifier:  NCT00115258
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-05