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Completed

NCT Number: NCT00115258

Nutrition Support in Pediatric Stem Cell Transplantation

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.

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Key information

Conditions

Hematopoietic Stem Cell Transplantation

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

parenteral nutrition titrated to measured REE

Other

Primary outcomes

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

    Time frame: day 30

Secondary outcomes

  1. Body composition measured by DXA, BIA, and 4-site skinfolds.

    Time frame: baseline, day 30, and day 100

  2. Changes in body composition from baseline to day +100.

    Time frame: day 100

  3. Insulin resistance, defined by HOMA, at each time point.

    Time frame: baseline, day 30, and day 100

  4. Measured resting energy expenditure (REE) at each time point.

    Time frame: baseline, day 30, and day 100

  5. Changes in percent predicted REE between the two groups.

    Time frame: baseline, day 30, and day 100

  6. Correlation between body composition and measured REE.

    Time frame: baseline, day 30, and day 100

  7. Resumption of oral intake.

    Time frame: day 30

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Jun 22, 2005
Registry last updated
Feb 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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