Nutrition Supplement for Cystic Fibrosis

SC
Overseen ByStephanie Clinical Research Program Coordinato
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Ohio State University
Must be taking: Modulator
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a specific nutrition supplement is more effective for adults with cystic fibrosis, a condition affecting the lungs and digestive system. It compares a common supplement formula to one containing less common nutrient forms. Participants will take one of the supplements for six weeks, with blood tests conducted before and after to assess nutrient absorption and utilization. Individuals with cystic fibrosis who have pancreatic issues and are undergoing specific treatments might be suitable candidates for this trial. As an unphased trial, this study provides participants the opportunity to contribute to important research that could enhance nutritional care for cystic fibrosis patients.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you cannot participate if you are taking certain medications like azole antifungals or those that are sensitive CYP3A4 substrates. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that nutritional supplements, including those with less common nutrient types, are generally safe for people with cystic fibrosis. One study found that these supplements can improve appetite, nutrition, and lung function in these individuals. Other research has also shown that blood levels of certain vitamins, such as E and Selenium, increased significantly with supplementation, indicating good absorption by the body.

Although specific side effects for less common nutrient types aren't detailed, using supplements in cystic fibrosis care is common and usually safe. This trial compares different nutrient types, and both types of supplements are expected to be safe based on past experiences.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for cystic fibrosis because they explore the potential benefits of using uncommon nutrient forms, which aren't typically found in standard supplements. Most conventional supplements rely on widely used nutrient forms, but this trial is testing if these less common forms can provide unique advantages in managing cystic fibrosis. By introducing these alternative nutrient options, the study aims to uncover new ways to improve the health and well-being of individuals with this condition.

What evidence suggests that this trial's treatments could be effective for cystic fibrosis?

Studies have shown that people with cystic fibrosis often struggle to absorb fats, which also impacts their intake of essential vitamins like A, D, and E. This trial will compare two supplementation approaches. Participants in one group will receive supplements with conventional nutrient forms, while another group will receive supplements with less common nutrient forms. Research suggests that these less common forms might enhance nutrient absorption in individuals with cystic fibrosis, potentially improving their nutrition. For instance, certain treatments have increased blood levels of vitamin E without additional supplements. This indicates that different nutrient forms, not typically found in regular supplements, may more effectively boost nutrient levels. Improved nutrient levels could lead to overall health benefits for people with cystic fibrosis.12345

Who Is on the Research Team?

RA

Robert A Emeritus Professor

Principal Investigator

Ohio State University

KF

Karen Faculty Pulmonary Medicine Nationwide Children's Hospital

Principal Investigator

Nationwide Children's Hospital

Are You a Good Fit for This Trial?

This trial is for adults (18+) with cystic fibrosis and exocrine pancreatic insufficiency, who are currently taking a modulator medication and have normal liver tests.

Inclusion Criteria

I have been diagnosed with cystic fibrosis.
I have been diagnosed with exocrine pancreatic insufficiency.
I am 18 years old or older.
See 2 more

Exclusion Criteria

I am currently taking a Category A or B medication according to LiverTox.
I have recently taken high doses of vitamin D, vitamin E, or copper supplements.
Any other concern by investigator that the subject is inappropriate for inclusion
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the novel or standard nutrient forms for 6 weeks

6 weeks
2 visits (in-person) for blood draws pre- and post-intervention

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Common form supplementation
  • Uncommon nutrient supplementation

Trial Overview

The study compares two types of nutrition supplements—one common and one less typical—to see which works better in people with cystic fibrosis. Participants take the assigned supplement for 6 weeks, with blood tests before and after.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Non-common nutrient formsExperimental Treatment1 Intervention
Group II: Conventional nutrient formsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials
891
Recruited
2,659,000+

Citations

Update on the management of vitamins and minerals in cystic ...

Advancements in respiratory and nutrition management have significantly improved the survival of patients with cystic fibrosis (CF).

Nutritional impact of CFTR modulators in children with ...

We found that blood levels of vitamin E and Selenium were significantly increased under Lumacaftor/Ivacaftor, without a significant increase in supplementation.

Review Improving nutrition in cystic fibrosis: A systematic ...

Key results supported the benefits of comprehensive, individualized nutritional plans, high-fat, high-calorie diet including high-quality carbohydrates, and ...

NACFC 2023 | S26: The Evolution of CF Nutrition: A Review of ...

The cystic fibrosis nutrition landscape has been changing as new therapies have been introduced. This session reviews recent nutrition ...

Nutritional Management of Cystic Fibrosis

Oral nutritional supplements should be taken in addition to an optimised daily food intake. ▫ The use of ONS should be monitored for tolerance, ongoing need, ...