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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2003 by National Center for Research Resources (NCRR).
Recruitment status was:  Active, not recruiting
Indiana University School of Medicine
Information provided by:
National Center for Research Resources (NCRR) Identifier:
First received: September 11, 2000
Last updated: June 23, 2005
Last verified: December 2003

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.

Cystic Fibrosis

Study Type: Observational
Study Design: Observational Model: Natural History
Official Title: Study of Total Energy Expenditure in Infants and Children With Moderate to Severe Cystic Fibrosis

Resource links provided by NLM:

Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment: 60
Study Start Date: June 1996
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).


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


--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


  • 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)
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Please refer to this study by its identifier: NCT00006273

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
Study Chair: Catherine A. Leitch Indiana University
  More Information Identifier: NCT00006273     History of Changes
Other Study ID Numbers: NCRR-M01RR00750-9040
Study First Received: September 11, 2000
Last Updated: June 23, 2005

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:
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases processed this record on April 27, 2017