Cystic FibrosisNCT00006273
Study of Total Energy Expenditure in Infants and Children With Moderate to Severe Cystic Fibrosis
An observational study of Cystic Fibrosis, run by National Center for Research Resources (NCRR) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1996to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University
Indianapolis, Indiana, 46202-5167
About this study
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.
Read the 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).
- Conditions
- Cystic Fibrosis
- Keywords
- cardiovascular and respiratory diseases, cystic fibrosis, genetic diseases and dysmorphic syndromes, rare disease
- Medical subject headings
- Cystic Fibrosis, Respiratory Tract Diseases, Genetic Diseases, Inborn, Rare Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2000 (estimated)
- Study startJun 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Natural history
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Indiana University
- Investigators
- Catherine A. Leitch, Study chair, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006273
- Sponsor's protocol ID
- NCRR-M01RR00750-9040
- Other IDs
- IU-9509-20
- Status last verified
- Dec 2003
- First submitted
- 11 Sep 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Total Energy Expenditure in Infants and Children With Moderate to Severe Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00006273
- Acronym / sponsor ID
- NCRR-M01RR00750-9040
- Conditions
- Cystic Fibrosis
- Keywords
- cardiovascular and respiratory diseases, cystic fibrosis, genetic diseases and dysmorphic syndromes, rare disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- Collaborators
- Indiana University
- Study start
- Jun 1996
- First posted
- 12 Sep 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Natural history
Who may qualify
- Ages
- 0 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine A. Leitch study chair
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by National Center for Research Resources (NCRR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.