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Resting Energy Expenditure in Patients With Cystic Fibrosis: A Pilot Study

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ClinicalTrials.gov Identifier: NCT03699982
Recruitment Status : Recruiting
First Posted : October 9, 2018
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Amanda Dye, CAMC Health System

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Other: Daily calorie target based on resting energy expenditure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Resting Energy Expenditure in Patients With Cystic Fibrosis: A Pilot Study
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : October 8, 2019
Estimated Study Completion Date : October 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Experimental: Cystic fibrosis patients
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.
Other: Daily calorie target based on resting energy expenditure

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.





Primary Outcome Measures :
  1. Resting energy expenditure estimation [ Time Frame: 1 hour ]
    Resting energy expenditure will be obtained using indirect calorimetry and the Harris-Benedict Equation.

  2. 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).

  3. 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).



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Ages Eligible for Study:   6 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03699982


Contacts
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Contact: Amanda Dye, MD 304-388-1552 asdye@hsc.wvu.edu

Locations
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United States, West Virginia
CAMC - Women and Children's Hospital Recruiting
Charleston, West Virginia, United States, 25302
Sponsors and Collaborators
CAMC Health System
Investigators
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Principal Investigator: Amanda Dye, MD CAMC and WVU-Charleston

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Responsible Party: Amanda Dye, Assistant Professor, Department of Pediatrics, CAMC Health System
ClinicalTrials.gov Identifier: NCT03699982     History of Changes
Other Study ID Numbers: 18-501
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amanda Dye, CAMC Health System:
Cystic Fibrosis
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases