Nutrition Supplement for Cystic Fibrosis

NCT07163078 | Not Yet Recruiting

• 1 other identifier: GR134529
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Cystic Fibrosis (CF)

Keywords

Cystic Fibrosis; Vitamins; Copper; Choline

Outcome Measures

Primary Outcomes (7)

• Nutrient status assessor 1

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

  From pre-supplementation to 6 weeks later

• Nutrition status assessor 2

  Plasma concentrations of vitamin E (mg/L)

  From pre-supplementation to 6 weeks later

• Nutrition status assessor 3

  Plasma concentrations of CoQ10 (mg/L)

  From pre-supplementation to 6 weeks later

• Nutrition status assessor 4

  Plasma copper (µg/ml)

  From pre-supplementation to 6 weeks later

• Nutrition status assessor 5

  Plasma diamine oxidase activity (Units/L)

  From pre-supplementation to 6 weeks later

• Nutrition status assessor 6

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

  From pre-supplementation to 6 weeks later

• Nutrition status assessor 7

  Plasma choline (µM)

  From pre-supplementation to 6 weeks later

Secondary Outcomes (5)

• Functional implication indicator 1

  From pre-supplementation to 6 weeks later

• Functional implication indicator 2

  From pre-supplementation to 6 weeks later

• Functional implication indicator 3

  From pre-supplementation to 6 weeks later

• Functional implication indicator 4

  From pre-supplementation to 6 weeks later

• Subjective response

  From pre-supplementation to 6 weeks later

Study Arms (2)

Conventional nutrient forms

ACTIVE COMPARATOR

People are given a supplement with nutrient forms typically used in supplements

Dietary Supplement: Common form supplementation

Non-common nutrient forms

EXPERIMENTAL

People are given a supplement with nutrient forms that are not the most commonly used forms in supplements

Dietary Supplement: Uncommon nutrient supplementation

Interventions

Common form supplementation DIETARY_SUPPLEMENT

The intervention product would represent part of a typical supplement given to people including those with CF

Conventional nutrient forms

Uncommon nutrient supplementation DIETARY_SUPPLEMENT

The intervention product would represent part of a possible new supplement given to people including those with CF

Non-common nutrient forms

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with cystic fibrosis
• Diagnosed with exocrine pancreatic insufficiency
• years old or older
• Currently on modulator
• Normal liver enzyme labs

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ohio State University: lead

Related Publications (1)

• Best K, McCoy K, Gemma S, Disilvestro RA. Copper enzyme activities in cystic fibrosis before and after copper supplementation plus or minus zinc. Metabolism. 2004 Jan;53(1):37-41. doi: 10.1016/j.metabol.2003.07.017.

  PMID: 14681839 RESULT

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Robert A Emeritus Professor

  Ohio State University

  PRINCIPAL INVESTIGATOR

• Karen Faculty Pulmonary Medicine Nationwide Children's Hospital

  Nationwide Children's Hospital

  STUDY DIRECTOR

Central Study Contacts

Stephanie Clinical Research Program Coordinato

CONTACT

614-722-2000; Stephanie.Sliemers@nationwidechildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emeritus Pofessor

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: September 9, 2025
• Study Start: January 15, 2026
• Primary Completion: March 28, 2026
• Study Completion: April 27, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share