Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006273
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-09-11
Brief Title:
Study of Total Energy Expenditure in Infants and Children With Moderate to Severe Cystic Fibrosis
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
Study of Total Energy Expenditure in Infants and Children With Moderate to Severe Cystic Fibrosis
Status:
UNKNOWN
Status Verified Date:
2003-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IU-9509-20 | None | None | None |