Cystic FibrosisNCT03699982
Resting Energy Expenditure in Patients With Cystic Fibrosis: A Pilot Study
A study testing Daily calorie target based on resting energy expenditure in people with Cystic Fibrosis, run by CAMC Health System at 1 site in United States.
Trial summary
Cystic fibrosis is an inherited disorder that causes severe damage to the lungs, digestive system, and other organs in the body. Individuals with cystic fibrosis often have poor weight gain and growth that can negatively impact health further by worsening lung function. Read more about this study
- Who is it for?
- Ages 6 to 99 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Daily calorie target based on resting energy expenditure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2018to 20 Jan 2020
- Phase
- Interventional
- 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 6 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with cystic fibrosis who are equal to or older than six years of age presenting to West Virginia University-Charleston Cystic Fibrosis Center for their regularly scheduled appointments/check-ups.
- Patients at the Cystic Fibrosis Center for at least 12 months.
Who cannot join
- Patients with cystic fibrosis who are younger than 6 years of age.
- Patients without cystic fibrosis.
- Patients currently pregnant.
- Cystic fibrosis patients with significant disease exacerbation (such as needing oral steroids or antibiotics, hospital admission within 30 days) or patients who currently having the flu or a serious upper respiratory infection.
Trial locations and contacts
1 site in 1 country.
United States1 site
CAMC - Women and Children's Hospital
Charleston, West Virginia, 25302
About this study
Cystic fibrosis is an inherited disorder that causes severe damage to the lungs, digestive system, and other organs in the body. Individuals with cystic fibrosis often have poor weight gain and growth that can negatively impact health further by worsening lung function. Additionally, persons with the disease typically need more than the usual calories on a daily basis.
Most institutions estimate these patients' caloric needs using weight, age, and sex based mathematical formulae. However, numerous studies show that use of these formulae often yields inaccurate caloric values. Use of indirect calorimetry may give more accurate estimates of caloric needs in patients with cystic fibrosis.
Read more
The aim of our study is to assess the accuracy of caloric estimates generated using one such widely used mathematical formula, the Harris-Benedict equation, and to compare this calorie value with that obtained from indirect calorimetry testing in pediatric and adult patients with cystic fibrosis.
Study investigators will use the newly calculated caloric requirements in dietary counseling. Changes in weight and lung function after 3 months will be compared to participants' historical changes.
- Conditions
- Cystic Fibrosis
- Being tested
- Daily calorie target based on resting energy expenditure
- Keywords
- Cystic Fibrosis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily calorie target based on resting energy expenditureOther
Resting Energy Expenditure will be determined using the Harris-Benedict formula and indirect calorimetry testing. Additionally, a 48 Hour Dietary Recall will be completed to estimate approximate caloric intake at baseline.
Participants will be instructed to increase their daily calorie intake based on the highest REE/caloric intake, whether by indirect calorimetry, the Harris-Benedict formula, or patient's estimated current caloric intake.
| Study group | Role | What they receive |
|---|---|---|
| Cystic fibrosis patients | Experimental | Patients with cystic fibrosis who are six year or older, who regularly receive care at the West Virginia University-Charleston Cystic Fibrosis Center, and agreed to participate in the study. Receives: Other: Daily calorie target based on resting energy expenditure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting energy expenditure estimation
Resting energy expenditure will be obtained using indirect calorimetry and the Harris-Benedict Equation.
Measured: 1 hour
Morphological variable changes
Weight/height/BMI changes after 3 months of intervention and historical weight/height/BMI changes occurring during the 12 preceding months (reported as 3 month means).
Measured: 3 months
Changes in pulmonary function status
Changes in pulmonary function status, including FEV1%, after 3 months of intervention and historical pulmonary function status changes occurring during the 12 preceding months (reported as 3 month means).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start10 Oct 2018
- Primary completion20 Jan 2020
- Study completion20 Jan 2020
Why it stopped: PI left study institute.
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAMC Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amanda Dye, MD, Principal investigator, CAMC and WVU-Charleston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699982
- Sponsor's protocol ID
- 18-501
- Status last verified
- Nov 2024
- First submitted
- 4 Oct 2018
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resting Energy Expenditure in Patients With Cystic Fibrosis: A Pilot Study
- ClinicalTrials.gov ID
- NCT03699982
- Acronym / sponsor ID
- 18-501
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left study institute.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- CAMC Health SystemUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 9 Oct 2018 (actual)
- 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.
Cystic fibrosis is an inherited disorder that causes severe damage to the lungs, digestive system, and other organs in the body. Individuals with cystic fibrosis often have poor weight gain and growth that can negatively impact health further by worsening lung function. Additionally, persons with the disease typically need more than the usual calories on a daily basis.
Most institutions estimate these patients' caloric needs using weight, age, and sex based mathematical formulae. However, numerous studies show that use of these formulae often yields inaccurate caloric values. Use of indirect calorimetry may give more accurate estimates of caloric needs in patients with cystic fibrosis.
The aim of our study is to assess the accuracy of caloric estimates generated using one such widely used mathematical formula, the Harris-Benedict equation, and to compare this calorie value with that obtained from indirect calorimetry testing in pediatric and adult patients with cystic fibrosis.
Study investigators will use the newly calculated caloric requirements in dietary counseling. Changes in weight and lung function after 3 months will be compared to participants' historical changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cystic fibrosis patients | Experimental | Other: Daily calorie target based on resting energy expenditurePatients with cystic fibrosis who are six year or older, who regularly receive care at the West Virginia University-Charleston Cystic Fibrosis Center, and agreed to participate in the study. |
Who may qualify
- Ages
- 6 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with cystic fibrosis who are equal to or older than six years of age presenting to West Virginia University-Charleston Cystic Fibrosis Center for their regularly scheduled appointments/check-ups.
- Patients at the Cystic Fibrosis Center for at least 12 months.
Key exclusion criteria (4 listed)
- Patients with cystic fibrosis who are younger than 6 years of age.
- Patients without cystic fibrosis.
- Patients currently pregnant.
- Cystic fibrosis patients with significant disease exacerbation (such as needing oral steroids or antibiotics, hospital admission within 30 days) or patients who currently having the flu or a serious upper respiratory infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily calorie target based on resting energy expenditureResting Energy Expenditure will be determined using the Harris-Benedict formula and indirect calorimetry testing. Additionally, a 48 Hour Dietary Recall will be completed to estimate approximate caloric intake at baseline. Participants will be instructed to increase their daily calorie intake based on the highest REE/caloric intake, whether by indirect calorimetry, the Harris-Benedict formula, or patient's estimated current caloric intake. | Other | Cystic fibrosis patients |
Primary outcome
Resting energy expenditure estimation
Time frame: 1 hour
Resting energy expenditure will be obtained using indirect calorimetry and the Harris-Benedict Equation.
Morphological variable changes
Time frame: 3 months
Weight/height/BMI changes after 3 months of intervention and historical weight/height/BMI changes occurring during the 12 preceding months (reported as 3 month means).
Changes in pulmonary function status
Time frame: 3 months
Changes in pulmonary function status, including FEV1%, after 3 months of intervention and historical pulmonary function status changes occurring during the 12 preceding months (reported as 3 month means).
Results and safety
The study was stopped early (reason given: PI left study institute.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Amanda Dye, MD principal investigator
CAMC and WVU-Charleston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily calorie target based on resting energy expenditure in people with Cystic Fibrosis, run by CAMC Health System 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?
The sponsor lists 2 inclusion and 4 exclusion criteria. 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: stopped early, as of the sponsor's last update on 18 Nov 2024. 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?
The study was stopped early (reason given: PI left study institute.). 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.
What does the primary outcome measure?
Resting energy expenditure estimation (time frame: 1 hour). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 18 Nov 2024.