Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Indianapolis, Indiana 46202


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.


Study summary:

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).


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)


NCT ID:

NCT00006273


Primary Contact:

Study Chair
Catherine A. Leitch
Indiana University


Backup Contact:

N/A


Location Contact:

Indianapolis, Indiana 46202
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.