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

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ClinicalTrials.gov Identifier: NCT03462056
Recruitment Status : Not yet recruiting
First Posted : March 12, 2018
Last Update Posted : March 14, 2018
Sponsor:
Collaborator:
Cystic Fibrosis Foundation Therapeutics
Information provided by (Responsible Party):
Washington University School of Medicine

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis
U.S. FDA Resources

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



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)



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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.

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): NCT03462056


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

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03462056     History of Changes
Other Study ID Numbers: 201712139
First Posted: March 12, 2018    Key Record Dates
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