Back to resultsReady to Use Therapeutic Food (RUTF) to Promote Growth in Cystic Fibrosis
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cystic Fibrosis Ready to Use Supplemental Food
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis
Eligibility Criteria
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.
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CF Ready to Use Supplemental Food.
Arm Description
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
Outcomes
Primary Outcome Measures
BMI Z-score
Change in BMI Z-score
Secondary Outcome Measures
Weight Z-score
Change in Weight Z-score
Body Composition
Percent body fat mass and lean mass as measured by air displacement plethysmography
Body Composition
Percent body fat mass and lean mass as estimated by skinfold measurements (triceps and subscapular)
Pulmonary Function
Change in percent estimated forced expiratory volume at one second (FEV1), and forced vital capacity (FVC)
Compliance of taking supplemental food
Percent consumed as compared to amount recommended.
Quality of Life
Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Full Information
NCT ID
NCT03462056
First Posted
March 5, 2018
Last Updated
June 19, 2019
Sponsor
Washington University School of Medicine
Collaborators
Cystic Fibrosis Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03462056
Brief Title
Ready to Use Therapeutic Food (RUTF) to Promote Growth in Cystic Fibrosis
Official Title
Pilot Study of Ready to Use Therapeutic Food to Promote Weight Gain in Cystic Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
May 17, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
June 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Cystic Fibrosis Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CF Ready to Use Supplemental Food.
Arm Type
Experimental
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Cystic Fibrosis Ready to Use Supplemental Food
Intervention Description
Specially formulated for use by children with Cystic Fibrosis
Primary Outcome Measure Information:
Title
BMI Z-score
Description
Change in BMI Z-score
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Weight Z-score
Description
Change in Weight Z-score
Time Frame
3 months
Title
Body Composition
Description
Percent body fat mass and lean mass as measured by air displacement plethysmography
Time Frame
3 months
Title
Body Composition
Description
Percent body fat mass and lean mass as estimated by skinfold measurements (triceps and subscapular)
Time Frame
3 months
Title
Pulmonary Function
Description
Change in percent estimated forced expiratory volume at one second (FEV1), and forced vital capacity (FVC)
Time Frame
3 months
Title
Compliance of taking supplemental food
Description
Percent consumed as compared to amount recommended.
Time Frame
3 months
Title
Quality of Life
Description
Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan T Pitman, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark J Manary, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ready to Use Therapeutic Food (RUTF) to Promote Growth in Cystic Fibrosis
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