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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00006273

Enrollment

Registered

2000-09-12

Start date

1996-06-30

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

cardiovascular and respiratory diseases, cystic fibrosis, genetic diseases and dysmorphic syndromes, rare disease

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

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).

Interventions

None listed

Study design

Observational model

NATURAL_HISTORY

Eligibility

Sex/Gender

ALL

Age

0 Years to 10 Years

Healthy volunteers

Yes

Inclusion 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)

Countries

United States

Outcome results