Cystic FibrosisPhase 1/2NCT03462056
Ready to Use Therapeutic Food (RUTF) to Promote Growth in Cystic Fibrosis
A Phase 1/2 study testing Cystic Fibrosis Ready to Use Supplemental Food in people with Cystic Fibrosis, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Cystic Fibrosis Ready to Use Supplemental Food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2018to 14 Jun 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Cystic Fibrosis Ready to Use Supplemental Food
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cystic Fibrosis Ready to Use Supplemental FoodDietary supplement
Specially formulated for use by children with Cystic Fibrosis
| Study group | Role | What they receive |
|---|---|---|
| CF Ready to Use Supplemental Food. | Experimental | 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 Receives: Dietary Supplement: Cystic Fibrosis Ready to Use Supplemental Food |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI Z-score
Change in BMI Z-score
Measured: 3 months
Secondary outcomes (6)
Weight Z-score
Change in Weight Z-score
Measured: 3 months
Body Composition
Percent body fat mass and lean mass as measured by air displacement plethysmography
Measured: 3 months
Body Composition
Percent body fat mass and lean mass as estimated by skinfold measurements (triceps and subscapular)
Measured: 3 months
Pulmonary Function
Change in percent estimated forced expiratory volume at one second (FEV1), and forced vital capacity (FVC)
Measured: 3 months
Compliance of taking supplemental food
Percent consumed as compared to amount recommended.
Measured: 3 months
Quality of Life
Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start17 May 2018
- Primary completion30 Apr 2019
- Study completion14 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Sponsor
- Investigators
- Ryan T Pitman, M.D., Principal investigator, Washington University School of MedicineMark J Manary, M.D., Study chair, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462056
- Sponsor's protocol ID
- 201712139
- Status last verified
- Jun 2019
- First submitted
- 5 Mar 2018
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Ready to Use Therapeutic Food to Promote Weight Gain in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03462056
- Acronym / sponsor ID
- 201712139
- Conditions
- Cystic Fibrosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- 17 May 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 14 Jun 2019 (actual)
- First posted
- 12 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CF Ready to Use Supplemental Food. | Experimental | Dietary Supplement: Cystic Fibrosis Ready to Use Supplemental FoodParticipants 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 |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cystic Fibrosis Ready to Use Supplemental FoodSpecially formulated for use by children with Cystic Fibrosis | Dietary supplement | CF Ready to Use Supplemental Food. |
Primary outcome
BMI Z-score
Time frame: 3 months
Change in BMI Z-score
6 secondary outcomes
Weight Z-score
Time frame: 3 months
Body Composition
Time frame: 3 months
Body Composition
Time frame: 3 months
Pulmonary Function
Time frame: 3 months
Compliance of taking supplemental food
Time frame: 3 months
Quality of Life
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan T Pitman, M.D. principal investigator
Washington University School of Medicine
Mark J Manary, M.D. study chair
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cystic Fibrosis Ready to Use Supplemental Food in people with Cystic Fibrosis, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI Z-score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2019.