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

Sponsor

National Center for Research Resources (NCRR) (NIH)

Overall Status

Unknown status

CT.gov ID

NCT00006273

Collaborator

Indiana University School of Medicine (Other)

Enrollment

Location

Study Details

Study Description

Brief Summary

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.

Determine the total energy expenditure and energy spent on physical activity using the doubly labeled water method in these patient populations.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis

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).

Study Design

Study Type:

Observational

Observational Model:

Natural History

Official Title:

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

Study Start Date :

Jun 1, 1996

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)