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NCT07163078
Nutrition Supplement for Cystic Fibrosis
Conditions: Cystic Fibrosis (CF)
Sex: All
Ages: 18 Years – 50 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Ohio State University
Location: Nationwide Children's Hospital-Ohio State University Columbus Ohio
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 versions of certain nutrients outperform typical versions of these nutrients? This will be determined by examining blood measures of nutrient levels and/or indications of nutrient function indicators pre- and post-intervention. Participants will take the supplements for 6 weeks with a blood draw before and after that time.
Eligibility Criteria
Inclusion Criteria:
* Diagnosed with cystic fibrosis
* Diagnosed with exocrine pancreatic insufficiency
* 18 years old or older
* Currently on modulator
* Normal liver enzyme labs
Exclusion Criteria: :
* 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
Source: ClinicalTrials.gov (NCT07163078). StuddyBuddy aggregates publicly available trial information.