Status:
NOT_YET_RECRUITING
Nutrition Supplement for Cystic Fibrosis
Lead Sponsor:
Ohio State University
Conditions:
Cystic Fibrosis (CF)
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
The goal of this study is to learn if one nutrition supplement formula works better than a different formula in adults with cystic fibrosis. The main question being addressed is: Will certain atypical...
Detailed Description
Background. For people with cystic fibrosis (CF), new drugs have extended life expectancy and improved quality of life. Yet, even with these improvements, people with CF still face shorter than normal...
Eligibility Criteria
Inclusion
- Diagnosed with cystic fibrosis
- Diagnosed with exocrine pancreatic insufficiency
- 18 years old or older
- Currently on modulator
- Normal liver enzyme labs
Exclusion
- :
- Non-English-speaking participants
- Acute health crisis
- Persistent elevation of liver enzymes \>6 months (E2) (ALT \>80 U/L)
- History of liver abnormalities
- If patients are currently taking Category A or Category B in the LiverTox categorization system
- Recent vitamin D supplementation of 30 mcg/day or higher, vitamin E supplements of 200 IU/day or higher, or copper at 2 mg/day or higher
- Any other concern by investigator that the subject is inappropriate for inclusion
- Patients who is on a reduced dose of a CFTR modulator
- Patients on azole antifungals (voriconazole, itraconazole, posaconzole, \>7 days of fluconazole, etc.).
- Patients who binge drink EtOH - for men more than 2 drinks/day, for women more than 1 drink/ day
- Patients that are on other medications that are sensitive CYP3A4 substrates - such as tacrolimus for example
- Patients on sensitive CYP3A4 substrates including but not limited to tacrolimus, sirolimus, and cyclosporine
Key Trial Info
Start Date :
January 15 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 27 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07163078
Start Date
January 15 2026
End Date
April 27 2026
Last Update
December 19 2025
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