An interventional study of Common form supplementation and Uncommon nutrient supplementation in Cystic Fibrosis (CF), sponsored by Ohio State University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Ohio State University · Not applicable, Interventional, and Supportive care
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Among 717 studies in Cystic Fibrosis with a site in United States — 86 open to participants now, 111 under way, 8 of them phase 3. Cystic Fibrosis · United States.
Among the 717 studies in Cystic Fibrosis with a site in United States, this one is the 183rd largest by planned enrollment of the 517 interventional ones that give a count, is one of 16 that started in 2026, is one of 155 with no phase, reaches primary completion later than 42 of the 108 other live ones, and was the 697th registered.
1,621 studies on the registry are indexed under Cystic Fibrosis; 201 are open to participants now.
Browse Cystic Fibrosis studies →86 of the 717 studies in Cystic Fibrosis with a site in United States are open now. Recruiting first, the newest first:
Bettina Mittendorfer · Sites in United States
Ages 18–100 · Healthy volunteers
Aimmune Nestlé Health Science US R&D, LLC · Sites in United States, Bulgaria, Hungary and 4 more countries
Ages 18–85
Dartmouth-Hitchcock Medical Center · Sites in United States
Ages 3–18
Ghady Haidar · Sites in United States
Ages 18+
Anagram Therapeutics, Inc. · Sites in United States
Ages 12+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 156 Cystic Fibrosis studies recruiting now, 95 (61%) set no upper age limit and 45 (29%) stop at 75 or younger; 86 take children under 18; 41 take healthy volunteers.
This study: 18 Years to 50 Years · all sexes · no healthy volunteers.
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717 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 109 · Phase 2 143 · Phase 3 108 · Phase 4 47
First in 1988; this study’s year is marked. 16 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is above the median of 36 across 1,053 interventional studies indexed under Cystic Fibrosis.
Median enrollment 36 across the 517 interventional studies, 80 across the 193 observational. Of the 569 that completed or were terminated, 263 (46%) have results posted.
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250 of 717 have an industry lead sponsor. The 10 most frequent:
Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.
Ohio State University has 2 studies filed under Cystic Fibrosis — fewer than ten, so there is no comparison to draw.
44 of the studies in Cystic Fibrosis with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06413368Phase 3Children's Hospital Los AngelesMaralixibat in Patients With Cystic Fibrosis and Constipation | 2027-06-30 |
| NCT06449677Phase 3Jaeb Center for Health ResearchBionic Pancreas in CFRD | 2027-06-30 |
| NCT06996951Phase 3Indiana UniversitySinonasal Therapies and Histologic Correlations of Patients With Cystic Fibrosis in the Era of Highly Effective Modulator Therapy | 2027-07 |
| NCT06237335ReCode TherapeuticsA Phase 2 Study Evaluating Safety and Tolerability of RCT2100 (CFTR mRNA) in Healthy Participants and in Participants With CF | 2026-11 |
| NCT03655223RTI InternationalEarly Check: Expanded Screening in Newborns | 2026-11-30 |
Add all 44 to your calendar (.ics) → With an account.
Among the 717 studies in Cystic Fibrosis with a site in United States, from their registry updates:
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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.
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.
Inclusion Criteria:
Exclusion Criteria: :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
People are given a supplement with nutrient forms typically used in supplements
Dietary Supplement: Common form supplementation
People are given a supplement with nutrient forms that are not the most commonly used forms in supplements
Dietary Supplement: Uncommon nutrient supplementation
The intervention product would represent part of a typical supplement given to people including those with CF
The intervention product would represent part of a possible new supplement given to people including those with CF
Nutrient status assessor 1
Plasma concentrations of 25-OH vitamin D (ng/ml)
Time frame: From pre-supplementation to 6 weeks later
Nutrition status assessor 2
Plasma concentrations of vitamin E (mg/L)
Time frame: From pre-supplementation to 6 weeks later
Nutrition status assessor 3
Plasma concentrations of CoQ10 (mg/L)
Time frame: From pre-supplementation to 6 weeks later
Nutrition status assessor 4
Plasma copper (µg/ml)
Time frame: From pre-supplementation to 6 weeks later
Nutrition status assessor 5
Plasma diamine oxidase activity (Units/L)
Time frame: From pre-supplementation to 6 weeks later
Nutrition status assessor 6
Erythrocyte copper superoxide dismutase activities (Units/ml packed cells)
Time frame: From pre-supplementation to 6 weeks later
Nutrition status assessor 7
Plasma choline (µM)
Time frame: From pre-supplementation to 6 weeks later
Functional implication indicator 1
Plasma glucose(mg/dL)
Time frame: From pre-supplementation to 6 weeks later
Functional implication indicator 2
Plasma oxidized LDL (ng/ml)
Time frame: From pre-supplementation to 6 weeks later
Functional implication indicator 3
Plasma alanine amino transferase (ALT)(Units/L)
Time frame: From pre-supplementation to 6 weeks later
Functional implication indicator 4
Plasma vitamin C-like reducing power (mg ascorbic acid equivalents/dL)
Time frame: 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)
Time frame: From pre-supplementation to 6 weeks later
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Confidentiality issues exist even if shared without identifiers
Start is estimated for Oct 2026; primary completion for Feb 2027, 3 months later.
Of 214 non-industry interventional studies with no phase under Cystic Fibrosis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 3 months is below that.
Counting every sponsor, half of 229 studies reached it within 23 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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