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

June 23, 2005 updated by: National Center for Research Resources (NCRR)

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 Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5167
        • Indiana University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 10 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Research Resources (NCRR)

Collaborators

Indiana University School of Medicine

Investigators

  • Study Chair: Catherine A. Leitch, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1996

Study Registration Dates

First Submitted

September 11, 2000

First Submitted That Met QC Criteria

September 11, 2000

First Posted (Estimate)

September 12, 2000

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

December 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCRR-M01RR00750-9040
  • IU-9509-20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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