The purpose of this study will be to evaluate the effects of a modified formulation of AquADEKs (AquADEKs-2) on markers of inflammation, antioxidant levels and oxidative stress. Cystic Fibrosis (CF) is a disease that affects the organs in the body such as the lungs. Some of the damage to the lungs of CF patients may be caused by something called oxidant/antioxidant imbalance and oxidative stress. Oxidation in the body is kind of what happens to an apple when it turns brown after being cut. And, just as a squeeze of lemon juice stops the oxidation of an apple, antioxidants can stop the rusting (or damage) inside our bodies by unstable oxygen molecules called free radicals. Free radicals can help fight off bacteria and viruses but too many of them do damage instead. Our bodies need antioxidants to keep things in balance so we have the right amount of free radicals. Many CF patients also have trouble digesting food and absorbing nutrients like vitamins. Many of the vitamins we rely on are antioxidants, like vitamins A, D, E, K and beta-carotene. In some people with CF, even though they take multivitamins and pancreatic enzymes, they still have low amounts of antioxidants. The investigators are looking to see if taking more vitamins and antioxidants will help CF patients. AquADEKs-2 is an investigational new drug (a drug that has not received approval by the Food and Drug Administration \[FDA\]). This research study is being done with the AquADEKs-2 compared to a control multivitamin. The study drug, AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium. The control multivitamin contains standard amounts of vitamins A, B, D, E, and K without additional antioxidant supplementation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
73
AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.
The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.
University Medical Center
Tucson, Arizona, United States
Children's Hospital Colorado
Aurora, Colorado, United States
The Nemours Children's Clinic
Orlando, Florida, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
University of Minnesota Children's Hospital
Minneapolis, Minnesota, United States
Women and Children's Hospital of Buffalo
Buffalo, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
...and 5 more locations
Change in Sputum Myeloperoxidase (MPO) Level
The primary outcome is the difference in 16 week mean change in log10 sputum myeloperoxidase levels between the AquADEKs-2 arm and the Control Multivitamin arm.
Time frame: Baseline (Visit 2) to Week 16 (Visit 4)
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence is defined as the number and percentage of participants with at least one event over the 18 week follow-up period.
Time frame: 18 weeks follow up
Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Rate is defined as the number of events per participant follow-up week.
Time frame: 18 weeks follow up
Change in Lung Function
Absolute Change in Forced Expiratory Volume over one second (FEV1) % predicted between Baseline and Week 16. Global Lung Initiative equations were used to calculate FEV1 %predicted.
Time frame: Baseline (Visit 2) to Week 16
Change in Growth Endpoints
Absolute change in Body Mass Index (BMI) (kg/m\^2) between Baseline and Week 16.
Time frame: Baseline (Visit 2) to Week 16
Time to First Pulmonary Exacerbation
Median time to first pulmonary exacerbation (PEx) between baseline (Visit 2) and end of follow up (Week 18)
Time frame: Baseline (Visit 2) to end of follow up (Week 18)
Number of Pulmonary Exacerbations
The total number of PEx between baseline (Visit 2) and end of follow up (Week 18).
Time frame: Baseline (Visit 2) to end of follow up (Week 18)
Number of Participants With Pulmonary Exacerbations
Number (%) with at least one protocol-defined PEx between baseline (Visit 2) and end of follow up (Week 18).
Time frame: Baseline (Visit 2) to end of follow up (Week 18)
Number of Participants Hospitalized
Number (%) of participants with at least one hospitalization between Baseline (Visit 2) and end of follow up (Week 18).
Time frame: Baseline (Visit 2) to end of followup (Week 18)
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