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NCT07163078

Nutrition Supplement for Cystic Fibrosis

Not Yet Recruiting
NAAges 18–50InterventionalSupportive care
Ohio State University
~60 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:Common form supplementationUncommon nutrient supplementation

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Nutrient status assessor 1
Measured over From pre-supplementation to 6 weeks later
+6 more outcomes measured

Conditions

Cystic Fibrosis (CF)

Explore related trials

Cystic Fibrosis

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Robert A Emeritus Professor · PRINCIPAL_INVESTIGATOR · Ohio State University
  • Karen Faculty Pulmonary Medicine Nationwide Children's Hospital · STUDY_DIRECTOR · Nationwide Children's Hospital

Who to contact

Stephanie Clinical Research Program Coordinato
[email protected]
614-722-2000
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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

What this trial measures

  • Nutrient status assessor 1From pre-supplementation to 6 weeks later

    Plasma concentrations of 25-OH vitamin D (ng/ml)

  • Nutrition status assessor 2From pre-supplementation to 6 weeks later

    Plasma concentrations of vitamin E (mg/L)

  • Nutrition status assessor 3From pre-supplementation to 6 weeks later

    Plasma concentrations of CoQ10 (mg/L)

  • Nutrition status assessor 4From pre-supplementation to 6 weeks later

    Plasma copper (µg/ml)

  • Nutrition status assessor 5From pre-supplementation to 6 weeks later

    Plasma diamine oxidase activity (Units/L)

  • Nutrition status assessor 6From pre-supplementation to 6 weeks later

    Erythrocyte copper superoxide dismutase activities (Units/ml packed cells)

  • Nutrition status assessor 7From pre-supplementation to 6 weeks later

    Plasma choline (µM)