Cystic Fibrosis (CF)NCT07163078
Nutrition Supplement for Cystic Fibrosis
A study testing Common form supplementation and Uncommon nutrient supplementation in people with Cystic Fibrosis (CF), run by Ohio State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cystic Fibrosis (CF)
- What is being tested?
- Common form supplementation and Uncommon nutrient supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 2 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with cystic fibrosis
- Diagnosed with exocrine pancreatic insufficiency
- 18 years old or older
- Currently on modulator
- Normal liver enzyme labs
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Stephanie Clinical Research Program Coordinato contact
United States1 site
Nationwide Children's Hospital-Ohio State University
Columbus, Ohio, 43016
About this study
Official title: A Medical Nutrition Supplement for Cystic Fibrosis
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.
Read the detailed description
Background. For people with cystic fibrosis (CF), new drugs have extended life expectancy and improved quality of life. Yet, even with these improvements, people with CF still face shorter than normal life spans and constant threats of quality of life disruptions. One approach to attacking these hardships consists of treating nutritional deficiencies. However, that's not as simple as just giving standard nutrients. People with CF have trouble transporting certain nutrients from the digestive system. In theory, giving nutrients in certain forms might get past the CF associated difficulties. However, the big question is: What forms would work?
The answer to this question can vary for different nutrients. For fat soluble vitamins D and E as well as coenzyme Q10 (CoQ10), which is vitamin-like in CF, the proposed solution may be to make the nutrients mix well with water (by using something called micellular versions). That's because these nutrients normally leave the digestive system into the blood by riding with ingested fats; that's a problem in CF because fat malabsorption occurs. Micellular forms could allow the nutrient to travel with water. Some micellular versions of fat soluble vitamins have been tested in people with CF, but the results were not ideal. A better approach could be to use nanoemulsion micellular versions of fat soluble nutrients.
For another nutrient, copper, there needs to not only be good absorption from the digestive system, but also a need to get the copper's to its functional molecules. This principal investigator for the current study has found that giving the normally well absorbed copper glycinate doesn't improve copper status in CF people. In contrast, this situation may be remedied by mixing copper glycinate with a well absorbed version of the nonessential nutrient curcumin (which could escort copper to the appropriate molecules).
Choline, an essential nutrient, can also be a concern for people with CF. Alpha-glyceryl phosphoryl (AGP)-choline may absorb better in these people than the more commonly used choline tartrate.
If the above mentioned non-standard nutrient forms can be shown to work better in people with CF, a new product could be made with the non-standard versions of vitamins D and E, CoQ10, copper, and choline. A formulation could also eventually include another 2 fat soluble vitamins as nanoemulsions as well as zinc + curcumin (since zinc may have the same problem-solution as copper). The product could also include other nutrients normally taken as part of a multi-nutrient supplement.
None of the hand picked versions of the nutrients noted above have been tested in CF people. Therefore, a new study will be done to test these versions for vitamins D and E, CoQ10, copper, and choline.
Hypothesis. This project seeks confirmation of this hypothesis: a formulation with non-standard nutrient versions can outperform conventional nutrients in people with CF. Positive results here can bring a product close to launch. However, one more short study in more people in another geographic location can add more launch justification. A new study can also test the utility of adding 3 nutrients that should work better in versions like those tested in the current project.
Methods. A 6 week intervention is to be used. This principal investigator has used this length in many supplement studies and found it sufficient for altering nutritional function status. For example, this principal investigator has shown a strong change in copper status after 6 weeks of supplementation. Others have seen the same thing for 6 weeks or less for studies on vitamin E.
The new study will be double blind with subjects not knowing whether they are getting the novel or standard nutrient forms. The 2 formulas being tested are as follows:
Supplement 1 Conventional Vitamin D/Vitamin E/Coenzyme Q10. Copper glycinate. Choline tartrate
Supplement 2 Nanoemulsion Vitamin D/ Vitamin E/Coenzyme Q10. Copper glycinate + curcumin. AGP Choline
Daily doses for both supplements 1500 IU Vitamin D3 200; IU Vitamin E; 100 mg Coenzyme Q10; 2.5 mg; 250 mg Choline
Endpoints will be blood assessments for the status of the various nutrients. Some other blood measures will be done that relate to some of the functional implications of improving the status of the nutrients under study.
- Conditions
- Cystic Fibrosis (CF)
- Being tested
- Common form supplementation, Uncommon nutrient supplementation
- Keywords
- Cystic Fibrosis, Vitamins, Copper, Choline
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Common form supplementationDietary supplement
The intervention product would represent part of a typical supplement given to people including those with CF
Uncommon nutrient supplementationDietary supplement
The intervention product would represent part of a possible new supplement given to people including those with CF
| Study group | Role | What they receive |
|---|---|---|
| Conventional nutrient forms | Active comparator | People are given a supplement with nutrient forms typically used in supplements Receives: 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 Receives: Dietary Supplement: Uncommon nutrient supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutrient status assessor 1
Plasma concentrations of 25-OH vitamin D (ng/ml)
Measured: From pre-supplementation to 6 weeks later
Nutrition status assessor 2
Plasma concentrations of vitamin E (mg/L)
Measured: From pre-supplementation to 6 weeks later
Nutrition status assessor 3
Plasma concentrations of CoQ10 (mg/L)
Measured: From pre-supplementation to 6 weeks later
Nutrition status assessor 4
Plasma copper (µg/ml)
Measured: From pre-supplementation to 6 weeks later
Nutrition status assessor 5
Plasma diamine oxidase activity (Units/L)
Measured: From pre-supplementation to 6 weeks later
Nutrition status assessor 6
Erythrocyte copper superoxide dismutase activities (Units/ml packed cells)
Measured: From pre-supplementation to 6 weeks later
Nutrition status assessor 7
Plasma choline (µM)
Measured: From pre-supplementation to 6 weeks later
Secondary outcomes (5)
Functional implication indicator 1
Plasma glucose(mg/dL)
Measured: From pre-supplementation to 6 weeks later
Functional implication indicator 2
Plasma oxidized LDL (ng/ml)
Measured: From pre-supplementation to 6 weeks later
Functional implication indicator 3
Plasma alanine amino transferase (ALT)(Units/L)
Measured: From pre-supplementation to 6 weeks later
Functional implication indicator 4
Plasma vitamin C-like reducing power (mg ascorbic acid equivalents/dL)
Measured: From pre-supplementation to 6 weeks later
Subjective response
Cystic Fibrosis Questionnaire-Revised (CFQ-R): 0-100 scale with higher scores indicating better quality of life)
Measured: From pre-supplementation to 6 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start15 Oct 2026 (estimated)
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic Fibrosis (CF)Studies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert DiSilvestro, Ohio State University
- Investigators
- Robert A Emeritus Professor, Principal investigator, Ohio State UniversityKaren Faculty Pulmonary Medicine Nationwide Children's Hospital, Study director, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163078
- Sponsor's protocol ID
- GR134529
- Status last verified
- May 2026
- First submitted
- 25 Jun 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidentiality issues exist even if shared without identifiers
Publications
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.
PubMed 14681839
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Medical Nutrition Supplement for Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT07163078
- Acronym / sponsor ID
- GR134529
- Conditions
- Cystic Fibrosis (CF)
- Keywords
- Cystic Fibrosis, Vitamins, Copper, Choline
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background. For people with cystic fibrosis (CF), new drugs have extended life expectancy and improved quality of life. Yet, even with these improvements, people with CF still face shorter than normal life spans and constant threats of quality of life disruptions. One approach to attacking these hardships consists of treating nutritional deficiencies. However, that's not as simple as just giving standard nutrients. People with CF have trouble transporting certain nutrients from the digestive system. In theory, giving nutrients in certain forms might get past the CF associated difficulties. However, the big question is: What forms would work?
The answer to this question can vary for different nutrients. For fat soluble vitamins D and E as well as coenzyme Q10 (CoQ10), which is vitamin-like in CF, the proposed solution may be to make the nutrients mix well with water (by using something called micellular versions). That's because these nutrients normally leave the digestive system into the blood by riding with ingested fats; that's a problem in CF because fat malabsorption occurs. Micellular forms could allow the nutrient to travel with water. Some micellular versions of fat soluble vitamins have been tested in people with CF, but the results were not ideal. A better approach could be to use nanoemulsion micellular versions of fat soluble nutrients.
For another nutrient, copper, there needs to not only be good absorption from the digestive system, but also a need to get the copper's to its functional molecules. This principal investigator for the current study has found that giving the normally well absorbed copper glycinate doesn't improve copper status in CF people. In contrast, this situation may be remedied by mixing copper glycinate with a well absorbed version of the nonessential nutrient curcumin (which could escort copper to the appropriate molecules).
Choline, an essential nutrient, can also be a concern for people with CF. Alpha-glyceryl phosphoryl (AGP)-choline may absorb better in these people than the more commonly used choline tartrate.
If the above mentioned non-standard nutrient forms can be shown to work better in people with CF, a new product could be made with the non-standard versions of vitamins D and E, CoQ10, copper, and choline. A formulation could also eventually include another 2 fat soluble vitamins as nanoemulsions as well as zinc + curcumin (since zinc may have the same problem-solution as copper). The product could also include other nutrients normally taken as part of a multi-nutrient supplement.
None of the hand picked versions of the nutrients noted above have been tested in CF people. Therefore, a new study will be done to test these versions for vitamins D and E, CoQ10, copper, and choline.
Hypothesis. This project seeks confirmation of this hypothesis: a formulation with non-standard nutrient versions can outperform conventional nutrients in people with CF. Positive results here can bring a product close to launch. However, one more short study in more people in another geographic location can add more launch justification. A new study can also test the utility of adding 3 nutrients that should work better in versions like those tested in the current project.
Methods. A 6 week intervention is to be used. This principal investigator has used this length in many supplement studies and found it sufficient for altering nutritional function status. For example, this principal investigator has shown a strong change in copper status after 6 weeks of supplementation. Others have seen the same thing for 6 weeks or less for studies on vitamin E.
The new study will be double blind with subjects not knowing whether they are getting the novel or standard nutrient forms. The 2 formulas being tested are as follows:
Supplement 1 Conventional Vitamin D/Vitamin E/Coenzyme Q10. Copper glycinate. Choline tartrate
Supplement 2 Nanoemulsion Vitamin D/ Vitamin E/Coenzyme Q10. Copper glycinate + curcumin. AGP Choline
Daily doses for both supplements 1500 IU Vitamin D3 200; IU Vitamin E; 100 mg Coenzyme Q10; 2.5 mg; 250 mg Choline
Endpoints will be blood assessments for the status of the various nutrients. Some other blood measures will be done that relate to some of the functional implications of improving the status of the nutrients under study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional nutrient forms | Active comparator | Dietary Supplement: Common form supplementationPeople are given a supplement with nutrient forms typically used in supplements |
| Non-common nutrient forms | Experimental | Dietary Supplement: Uncommon nutrient supplementationPeople are given a supplement with nutrient forms that are not the most commonly used forms in supplements |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosed with cystic fibrosis
- Diagnosed with exocrine pancreatic insufficiency
- 18 years old or older
- Currently on modulator
- Normal liver enzyme labs
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Common form supplementationThe intervention product would represent part of a typical supplement given to people including those with CF | Dietary supplement | Conventional nutrient forms |
| Uncommon nutrient supplementationThe intervention product would represent part of a possible new supplement given to people including those with CF | Dietary supplement | Non-common nutrient forms |
Primary outcome
Nutrient status assessor 1
Time frame: From pre-supplementation to 6 weeks later
Plasma concentrations of 25-OH vitamin D (ng/ml)
Nutrition status assessor 2
Time frame: From pre-supplementation to 6 weeks later
Plasma concentrations of vitamin E (mg/L)
Nutrition status assessor 3
Time frame: From pre-supplementation to 6 weeks later
Plasma concentrations of CoQ10 (mg/L)
Nutrition status assessor 4
Time frame: From pre-supplementation to 6 weeks later
Plasma copper (µg/ml)
Nutrition status assessor 5
Time frame: From pre-supplementation to 6 weeks later
Plasma diamine oxidase activity (Units/L)
Nutrition status assessor 6
Time frame: From pre-supplementation to 6 weeks later
Erythrocyte copper superoxide dismutase activities (Units/ml packed cells)
Nutrition status assessor 7
Time frame: From pre-supplementation to 6 weeks later
Plasma choline (µM)
5 secondary outcomes
Functional implication indicator 1
Time frame: From pre-supplementation to 6 weeks later
Functional implication indicator 2
Time frame: From pre-supplementation to 6 weeks later
Functional implication indicator 3
Time frame: From pre-supplementation to 6 weeks later
Functional implication indicator 4
Time frame: From pre-supplementation to 6 weeks later
Subjective response
Time frame: From pre-supplementation to 6 weeks later
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Results publication: PubMed 14681839Best 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.
- Individual participant dataSharing planned: No. Confidentiality issues exist even if shared without identifiers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephanie Clinical Research Program Coordinato contact
Robert A Emeritus Professor principal investigator
Ohio State University
Karen Faculty Pulmonary Medicine Nationwide Children's Hospital study director
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Common form supplementation and Uncommon nutrient supplementation in people with Cystic Fibrosis (CF), run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Clinical Research Program Coordinato (614-722-2000, Stephanie.Sliemers@nationwidechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutrient status assessor 1 (time frame: From pre-supplementation to 6 weeks later). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07163078, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.