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

Phase 1

Completed

• Conditions: Cystic Fibrosis
• Interventions: Dietary Supplement: Cystic Fibrosis Ready to Use Supplemental Food

• Registration Number: NCT03462056
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-05
• Study First Submitted QC: 2018-03-05
• Study First Posted: 2018-03-12
• Study Start: 2018-05-17
• Primary Completion: 2019-04-30
• Status Verified: 2019-06
• Study Completion: 2019-06-14
• Last Update Submitted: 2019-06-19
• Last Update Posted: 2019-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CF Ready to Use Supplemental Food.	Cystic Fibrosis 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

Primary Outcome Measures

Name	Time	Method
BMI Z-score	3 months	Change in BMI Z-score

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States