Study of Total Energy Expenditure in Infants and Children With Moderate to Severe Cystic Fibrosis - Full Text View

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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	National Center for Research Resources (NCRR) 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

Genetics Home Reference related topics:

cystic fibrosis

MedlinePlus related topics:

Cystic Fibrosis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History

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

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

Study ID Numbers:	NCRR-M01RR00750-9040, IU-9509-20
First Received:	September 11, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00006273
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

Study placed in the following topic categories:

Digestive System Diseases

Genetic Diseases, Inborn

Respiratory Tract Diseases

Cystic Fibrosis

Fibrosis

Lung Diseases

Respiration Disorders

Rare Diseases

Infant, Newborn, Diseases

Pancreatic Diseases

Cystic fibrosis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on December 03, 2008