Nutrition Supplement for Cystic Fibrosis (NCT07163078) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Nutrition Supplement for Cystic Fibrosis
United States60 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Nutrient status assessor 1
Timeframe: From pre-supplementation to 6 weeks later
2
Nutrition status assessor 2
Timeframe: From pre-supplementation to 6 weeks later
3
Nutrition status assessor 3
Timeframe: From pre-supplementation to 6 weeks later
4
Nutrition status assessor 4
Timeframe: From pre-supplementation to 6 weeks later
5
Nutrition status assessor 5
Timeframe: From pre-supplementation to 6 weeks later
6
Nutrition status assessor 6
Timeframe: From pre-supplementation to 6 weeks later
7
Nutrition status assessor 7
Timeframe: From pre-supplementation to 6 weeks later