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
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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 |

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
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Dietary Supplement: Cystic Fibrosis Ready to Use Supplemental Food
Specially formulated for use by children with Cystic Fibrosis
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- BMI Z-score [ Time Frame: 3 months ]Change in BMI Z-score
- 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)

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Ages Eligible for Study: | 2 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Contact: Ryan T Pitman, M.D. | 314-454-4173 | rpitman@wustl.edu |
United States, Missouri | |
Washington University School of Medicine | Not yet recruiting |
Saint Louis, Missouri, United States, 63110 |
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 |