Ready to Use Therapeutic Food (RUTF) to Promote Growth in Cystic Fibrosis
Pilot Study of Ready to Use Therapeutic Food to Promote Weight Gain in Cystic Fibrosis
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 5, 2018
CompletedFirst Posted
Study publicly available on registry
March 12, 2018
CompletedStudy Start
First participant enrolled
May 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2019
CompletedJune 20, 2019
June 1, 2019
12 months
March 5, 2018
June 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
BMI Z-score
Change in BMI Z-score
3 months
Secondary Outcomes (6)
Weight Z-score
3 months
Body Composition
3 months
Body Composition
3 months
Pulmonary Function
3 months
Compliance of taking supplemental food
3 months
- +1 more secondary outcomes
Study Arms (1)
CF Ready to Use Supplemental Food.
EXPERIMENTALParticipants 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
Interventions
Specially formulated for use by children with Cystic Fibrosis
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2018
First Posted
March 12, 2018
Study Start
May 17, 2018
Primary Completion
April 30, 2019
Study Completion
June 14, 2019
Last Updated
June 20, 2019
Record last verified: 2019-06