- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03462056
Ready to Use Therapeutic Food (RUTF) to Promote Growth in Cystic Fibrosis
June 19, 2019 updated by: Washington University School of Medicine
Pilot Study of Ready to Use Therapeutic Food to Promote Weight Gain in Cystic Fibrosis
Children with cystic fibrosis require increased caloric intake to maintain appropriate growth, an important determinant of long-term outcomes.
This study seeks to determine the feasibility of using a novel therapeutic food to promote weight gain and growth in children with cystic fibrosis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Cystic Fibrosis diagnosed by sweat test or genetic testing.
- Exocrine Pancreatic Insufficiency and receiving pancreatic enzyme replacement therapy
- BMI or weight for age of less than the 50th percentile
Exclusion Criteria:
- Cystic fibrosis related diabetes mellitus
- Cystic fibrosis related liver disease.
- Anaphylactic or other allergy to peanut, cow's milk, oat flour or other RUTF ingredients.
- Patients who are status-post lung or liver transplantation
- Currently receiving enteral supplemental nutrition through gastrostomy or nasogastric tube.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CF Ready to Use Supplemental Food.
Participants will receive Cystic Fibrosis Ready to Use Supplemental Food sufficient to provide approximately 20% of estimated daily caloric needs up to 500kcal of total calories, 18.5 grams of protein and 28g of fat.
The supplement is also optimized to provide excellent protein quality and optimal polyunsaturated fatty acid composition
|
Specially formulated for use by children with Cystic Fibrosis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BMI Z-score
Time Frame: 3 months
|
Change in BMI Z-score
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight Z-score
Time Frame: 3 months
|
Change in Weight Z-score
|
3 months
|
Body Composition
Time Frame: 3 months
|
Percent body fat mass and lean mass as measured by air displacement plethysmography
|
3 months
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Body Composition
Time Frame: 3 months
|
Percent body fat mass and lean mass as estimated by skinfold measurements (triceps and subscapular)
|
3 months
|
Pulmonary Function
Time Frame: 3 months
|
Change in percent estimated forced expiratory volume at one second (FEV1), and forced vital capacity (FVC)
|
3 months
|
Compliance of taking supplemental food
Time Frame: 3 months
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Percent consumed as compared to amount recommended.
|
3 months
|
Quality of Life
Time Frame: 3 months
|
Cystic Fibrosis Questionnaire-Revised (CFQ-R)
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Ryan T Pitman, M.D., Washington University School of Medicine
- Study Chair: Mark J Manary, M.D., Washington University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 17, 2018
Primary Completion (Actual)
April 30, 2019
Study Completion (Actual)
June 14, 2019
Study Registration Dates
First Submitted
March 5, 2018
First Submitted That Met QC Criteria
March 5, 2018
First Posted (Actual)
March 12, 2018
Study Record Updates
Last Update Posted (Actual)
June 20, 2019
Last Update Submitted That Met QC Criteria
June 19, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201712139
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cystic Fibrosis
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Hospital de Clinicas de Porto AlegreUnknownCystic Fibrosis | Cystic Fibrosis Pulmonary Exacerbation | Cystic Fibrosis in Children | Cystic Fibrosis With ExacerbationBrazil
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University of Colorado, DenverCystic Fibrosis FoundationTerminatedCystic Fibrosis-related Diabetes | Cystic Fibrosis Pulmonary Exacerbation | Cystic Fibrosis in ChildrenUnited States
-
Royal College of Surgeons, IrelandThe Hospital for Sick Children; Imperial College London; Erasmus Medical Center; University College Dublin and other collaboratorsActive, not recruitingCystic Fibrosis | Adherence, Medication | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis in Children | Cystic Fibrosis Liver DiseaseUnited Kingdom, Ireland
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Herlev and Gentofte HospitalCopenhagen University Hospital, DenmarkActive, not recruitingMyocardial Infarction | Heart Diseases | Heart Failure | Stroke | Cystic Fibrosis | Heart Failure, Diastolic | Heart Failure, Systolic | Left Ventricular Dysfunction | Cystic Fibrosis-related Diabetes | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis of Pancreas | Cystic Fibrosis, Pulmonary | Cystic...Denmark
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The Hospital for Sick ChildrenCanadian Cystic Fibrosis FoundationActive, not recruitingCystic Fibrosis | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis in ChildrenCanada
-
Arrowhead PharmaceuticalsTerminatedCystic Fibrosis, PulmonaryAustralia, New Zealand
-
AzurRx SASCompletedCystic Fibrosis | Cystic Fibrosis Gastrointestinal Disease | Cystic Fibrosis of PancreasTurkey, Hungary
-
Dartmouth-Hitchcock Medical CenterTrustees of Dartmouth CollegeWithdrawnCystic Fibrosis-related Diabetes | Cystic Fibrosis Liver Disease | CF - Cystic FibrosisUnited States
-
University Hospital, BordeauxCompleted
-
University of PortsmouthUniversity Hospital Southampton NHS Foundation Trust; Loughborough University; Queen Alexandra HospitalTerminated
Clinical Trials on Cystic Fibrosis Ready to Use Supplemental Food
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University of WashingtonLa Clinique des Maladies Infectieuses, Centre Hospitalier National Universitaire...CompletedHIV and Tuberculosis Co-infection
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Makerere UniversityNUFUUnknownMalnutritionNorway, Uganda
-
Colorado State UniversityThrasher Research Fund; Savica, Indonesia; Institute of Research for Development...Active, not recruitingSevere Acute MalnutritionIndonesia
-
Tuberculosis Research Centre, IndiaLondon School of Hygiene and Tropical Medicine; Queen Mary University of London and other collaboratorsActive, not recruitingTuberculosis | Malnutrition, ChildIndia
-
Infectious Diseases InstituteUniversity of Dublin, Trinity CollegeUnknown
-
Aga Khan UniversityUnited Nations World Food Programme (WFP); People's Primary Healthcare Initiative...WithdrawnSevere Acute MalnutritionPakistan
-
UNICEF - VenezuelaTerminatedWasting | Acute Malnutrition in Childhood | Child MalnutritionVenezuela
-
Washington University School of MedicineKamuzu University of Health Sciences; Project Peanut Butter; Balchem CorpEnrolling by invitation
-
International Rescue CommitteeMinistry of health, Mali; University of the Sciences, Techniques and Technologies...Active, not recruitingAcute Malnutrition in Childhood | Underweight | Acute Malnutrition in InfancyMali
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Institut de Recherche pour le DeveloppementUnited Nations World Food Programme (WFP); UNICEF; Sidaction; Global FundCompletedHIV/AIDS | Malnutrition