This trial is active, not recruiting.

Condition cystic fibrosis
Sponsor National Center for Research Resources (NCRR)
Collaborator Indiana University School of Medicine
Start date June 1996
Trial size 60 participants
Trial identifier NCT00006273, IU-9509-20, NCRR-M01RR00750-9040


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model natural history

Eligibility Criteria

Male or female participants up to 10 years old.

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)

Additional Information

Official title Study of Total Energy Expenditure in Infants and Children With Moderate to Severe Cystic Fibrosis
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).
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by National Center for Research Resources (NCRR).