Ready to Use Therapeutic Food (RUTF) to Promote Growth in Cystic Fibrosis

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Cystic Fibrosis	Dietary Supplement: Cystic Fibrosis Ready to Use Supplemental Food	Phase 1; Phase 2

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	16 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Pilot Study of Ready to Use Therapeutic Food to Promote Weight Gain in Cystic Fibrosis
Estimated Study Start Date :	March 22, 2018
Estimated Primary Completion Date :	December 31, 2018
Estimated Study Completion Date :	December 31, 2018

Arms and Interventions

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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	Dietary Supplement: Cystic Fibrosis Ready to Use Supplemental Food; Specially formulated for use by children with Cystic Fibrosis

Outcome Measures

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Primary Outcome Measures :

1. BMI Z-score [ Time Frame: 3 months ]
   Change in BMI Z-score

Secondary Outcome Measures :

1. Weight Z-score [ Time Frame: 3 months ]
   Change in Weight Z-score
2. Body Composition [ Time Frame: 3 months ]
   Percent body fat mass and lean mass as measured by air displacement plethysmography
3. Body Composition [ Time Frame: 3 months ]
   Percent body fat mass and lean mass as estimated by skinfold measurements (triceps and subscapular)
4. Pulmonary Function [ Time Frame: 3 months ]
   Change in percent estimated forced expiratory volume at one second (FEV1), and forced vital capacity (FVC)
5. Compliance of taking supplemental food [ Time Frame: 3 months ]
   Percent consumed as compared to amount recommended.
6. Quality of Life [ Time Frame: 3 months ]
   Cystic Fibrosis Questionnaire-Revised (CFQ-R)

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	2 Years to 12 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Ryan T Pitman, M.D.	314-454-4173	rpitman@wustl.edu

Locations

United States, Missouri
Washington University School of Medicine	Not yet recruiting
Saint Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

Cystic Fibrosis Foundation Therapeutics

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT03462056 History of Changes
Other Study ID Numbers:	201712139
First Posted:	March 12, 2018
Last Update Posted:	March 14, 2018
Last Verified:	March 2018

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:

Fibrosis; Cystic Fibrosis; Pathologic Processes; Pancreatic Diseases; Digestive System Diseases	Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Infant, Newborn, Diseases