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

Overview

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.

Full Title of Study: “Pilot Study of Ready to Use Therapeutic Food to Promote Weight Gain in Cystic Fibrosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 30, 2019

Interventions

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

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • BMI Z-score
    • Time Frame: 3 months
    • Change in BMI Z-score

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Washington University School of Medicine
  • Collaborator
    • Cystic Fibrosis Foundation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ryan T Pitman, M.D., Principal Investigator, Washington University School of Medicine
    • Mark J Manary, M.D., Study Chair, Washington University School of Medicine

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