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| Sponsors and Collaborators: |
National Center for Research Resources (NCRR) Indiana University School of Medicine |
| Information provided by: | National Center for Research Resources (NCRR) |
| ClinicalTrials.gov Identifier: | NCT00006273 |
Purpose
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.
| Condition |
|
Cystic Fibrosis |
| Genetics Home Reference related topics: | cystic fibrosis |
| MedlinePlus related topics: | Cystic Fibrosis |
| Study Type: | Observational |
| Study Design: | Natural History |
| Official Title: | Study of Total Energy Expenditure in Infants and Children With Moderate to Severe Cystic Fibrosis |
| Estimated Enrollment: | 60 |
| Study Start Date: | June 1996 |
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).
Eligibility
| Ages Eligible for Study: | up to 10 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
OR
--Prior/Concurrent Therapy--
--Patient Characteristics--
Contacts and Locations| United States, Indiana | |||||
| Indiana University | |||||
| Indianapolis, Indiana, United States, 46202-5167 | |||||
| National Center for Research Resources (NCRR) |
| Indiana University School of Medicine |
| Study Chair: | Catherine A. Leitch | Indiana University |
More Information
| Study ID Numbers: | NCRR-M01RR00750-9040, IU-9509-20 |
| First Received: | September 11, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00006273 |
| Health Authority: | United States: Federal Government |
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