Effects of an Antioxidant-Enriched Multivitamin Supplement on Inflammation and Oxidative Stress in Cystic Fibrosis
Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
University of Colorado, Denver
Collaborators:
Cystic Fibrosis Foundation Cystic Fibrosis Foundation Therapeutics Yasoo Health