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

This study is ongoing, but not recruiting participants.

First Received: September 11, 2000 Last Updated: June 23, 2005 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Collaborator:	Indiana University School of Medicine
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00006273

Purpose

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
Cystic Fibrosis

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

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

U.S. FDA Resources

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).

Eligibility

Ages Eligible for Study:	up to 10 Years
Genders Eligible for Study:	Both
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

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

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

No publications provided

Study ID Numbers:	NCRR-M01RR00750-9040, IU-9509-20
Study First Received:	September 11, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00006273 History of Changes
Health Authority:	United States: Federal Government

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:

Pathologic Processes
Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis

Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on November 05, 2009