|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03462056 |
|
Date of registration:
|
05/03/2018 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Ready to Use Therapeutic Food (RUTF) to Promote Growth in Cystic Fibrosis
|
|
Scientific title:
|
Pilot Study of Ready to Use Therapeutic Food to Promote Weight Gain in Cystic Fibrosis |
|
Date of first enrolment:
|
May 17, 2018 |
|
Target sample size:
|
16 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03462056 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 1/Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Mark J Manary, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Washington University School of Medicine |
|
|
Name:
|
Ryan T Pitman, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Washington University School of Medicine |
| |
|
Key inclusion & exclusion criteria
|
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.
Age minimum:
2 Years
Age maximum:
12 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Cystic Fibrosis
|
|
Intervention(s)
|
|
Dietary Supplement: Cystic Fibrosis Ready to Use Supplemental Food
|
|
Primary Outcome(s)
|
|
BMI Z-score
[Time Frame: 3 months]
|
|
Secondary Outcome(s)
|
|
Compliance of taking supplemental food
[Time Frame: 3 months]
|
|
Weight Z-score
[Time Frame: 3 months]
|
|
Quality of Life
[Time Frame: 3 months]
|
|
Body Composition
[Time Frame: 3 months]
|
|
Pulmonary Function
[Time Frame: 3 months]
|
|
Secondary ID(s)
|
|
201712139
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|