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

NCT ID: NCT00006273

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

1996-06-30

Brief Summary

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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

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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).

Conditions

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Cystic Fibrosis

Keywords

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

Study Design

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Observational Model Type

NATURAL_HISTORY

Eligibility Criteria

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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)
Minimum Eligible Age

0 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indiana University School of Medicine

OTHER

Sponsor Role collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role lead

Principal Investigators

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Catherine A. Leitch

Role: STUDY_CHAIR

Indiana University

Locations

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Indiana University

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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IU-9509-20

Identifier Type: -

Identifier Source: secondary_id

NCRR-M01RR00750-9040

Identifier Type: -

Identifier Source: org_study_id