Study of Total Energy Expenditure in Infants and Children With Moderate to Severe Cystic Fibrosis

Sponsor
National Center for Research Resources (NCRR) (NIH)
Overall Status
Unknown status
CT.gov ID
NCT00006273
Collaborator
Indiana University School of Medicine (Other)
60
1

Study Details

Study Description

Brief Summary

OBJECTIVES: I. Compare the resting energy expenditure using respiratory calorimetry in infants and children with moderate to severe cystic fibrosis versus age matched healthy controls.

  1. Determine the total energy expenditure and energy spent on physical activity using the doubly labeled water method in these patient populations.
Condition or Disease Intervention/Treatment Phase

    Detailed Description

    PROTOCOL OUTLINE: Patients and healthy controls receive an oral dose of doubly labeled water following initial urine collection on day 1. Patients undergo additional urine collection at 4-6 hours following doubly labeled water consumption and then daily for 7 days.

    Additionally, at the beginning of the study, patients and healthy controls undergo respiratory calorimetry over approximately 45 minutes at rest, starting approximately 2-3 hours after the last meal consumption and last use of aerosol bronchodilators (if required).

    Study Design

    Study Type:
    Observational
    Observational Model:
    Natural History
    Official Title:
    Study of Total Energy Expenditure in Infants and Children With Moderate to Severe Cystic Fibrosis
    Study Start Date :
    Jun 1, 1996

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      0 Years to 10 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      PROTOCOL ENTRY CRITERIA:

      --Disease Characteristics--

      • Diagnosis of cystic fibrosis (CF) by two positive sweat tests No exacerbations of present condition within past 2 months FEV1 less than 50% of predicted No other uncorrected lung disease No requirement for supplemental oxygen

      OR

      • Healthy (control group) Age matched to CF patients No preexisting lung disease Clinically well No hospitalizations within past 6 months

      --Prior/Concurrent Therapy--

      • Concurrent pancreatic enzyme supplementation for CF required Clinically stable on current medications (CF patients)

      --Patient Characteristics--

      • Age: Birth to 12 months 6 to 10 years

      • Cardiovascular: No major cardiovascular problems (CF patients) No preexisting heart disease (control group)

      • Pulmonary: See Disease Characteristics

      • Other: No chromosomal abnormalities (CF patients) No acute infection (CF patients) No diabetes mellitus (both groups)

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Indiana University Indianapolis Indiana United States 46202-5167

      Sponsors and Collaborators

      • National Center for Research Resources (NCRR)
      • Indiana University School of Medicine

      Investigators

      • Study Chair: Catherine A. Leitch, Indiana University

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00006273
      Other Study ID Numbers:
      • NCRR-M01RR00750-9040
      • IU-9509-20
      First Posted:
      Sep 12, 2000
      Last Update Posted:
      Jun 24, 2005
      Last Verified:
      Dec 1, 2003

      Study Results

      No Results Posted as of Jun 24, 2005