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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03462056
• Other study ID #: 201712139
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 17, 2018
• Est. completion date: June 14, 2019

Study information

• Verified date: June 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 14, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Cystic Fibrosis Foundation

Country where clinical trial is conducted

United States, 

Outcome

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