Nutrition Supplement for Cystic Fibrosis
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.12345Why 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?
Robert A Emeritus Professor
Principal Investigator
Ohio State University
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the novel or standard nutrient forms for 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
People are given a supplement with nutrient forms that are not the most commonly used forms in supplements
People are given a supplement with nutrient forms typically used in supplements
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University
Lead Sponsor
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 ...
5.
cysticfibrosis.org.uk
cysticfibrosis.org.uk/sites/default/files/2020-12/Nutritional%20Management%20of%20cystic%20fibrosis%20Sep%2016.pdfNutritional 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, ...
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