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.
1This trial is listed as 'not yet recruiting' — do you know when it's expected to open, and would it make sense for me to wait for it or pursue other options in the meantime?
2The trial is in Phase NA and seems focused on measuring nutrition status in cystic fibrosis — can you help me understand what kind of nutrition supplement is being tested and what these nutrition assessments actually involve for me day-to-day?
3Since CF already requires a lot of careful nutritional management, how would joining this trial interact with my current diet, enzyme therapy, or any other supplements I'm already taking?
4The trial lists multiple different nutrition status assessors as its primary outcomes — does that mean the main goal is to understand nutritional gaps rather than to treat symptoms directly, and how might that affect what I personally gain from participating?
5Given that this trial hasn't started yet and the phase isn't specified, would you recommend I focus on established CF nutrition guidelines first, or is there a reason to keep an eye on this study as a potential next step in my care?
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