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

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ClinicalTrials.gov Identifier: NCT00006273
Recruitment Status : Unknown
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was:  Active, not recruiting
First Posted : September 12, 2000
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
Indiana University School of Medicine
Information provided by:
National Center for Research Resources (NCRR)

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.

II. Determine the total energy expenditure and energy spent on physical activity using the doubly labeled water method in these patient populations.


Condition or disease
Cystic Fibrosis

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 Type : Observational
Enrollment : 60 participants
Observational Model: Natural History
Official Title: Study of Total Energy Expenditure in Infants and Children With Moderate to Severe Cystic Fibrosis
Study Start Date : June 1996

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   up to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006273


Locations
United States, Indiana
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

ClinicalTrials.gov Identifier: NCT00006273     History of Changes
Other Study ID Numbers: NCRR-M01RR00750-9040
IU-9509-20
First Posted: September 12, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2003

Keywords provided by National Center for Research Resources (NCRR):
cardiovascular and respiratory diseases
cystic fibrosis
genetic diseases and dysmorphic syndromes
rare disease

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases