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

June 19, 2019 updated by: Washington University School of Medicine

Pilot Study of Ready to Use Therapeutic Food to Promote Weight Gain in Cystic Fibrosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI Z-score
Time Frame: 3 months
Change in BMI Z-score
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Cystic Fibrosis Foundation

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2018

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

June 14, 2019

Study Registration Dates

First Submitted

March 5, 2018

First Submitted That Met QC Criteria

March 5, 2018

First Posted (Actual)

March 12, 2018

Study Record Updates

Last Update Posted (Actual)

June 20, 2019

Last Update Submitted That Met QC Criteria

June 19, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201712139

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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