Effects of an Antioxidant-Enriched Multivitamin Supplement on Inflammation and Oxidative Stress in Cystic Fibrosis



Status:Completed
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:10 - Any
Updated:7/14/2016
Start Date:June 2013
End Date:July 2016

Use our guide to learn which trials are right for you!

A Multi-Center, Randomized, Controlled, Double-Blind Study of the Effects of an Antioxidant-Enriched Multivitamin Supplement on Inflammation and Oxidative Stress in Cystic Fibrosis Patients

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. We 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.


Inclusion Criteria:

- Male or female ≥10 years of age

- Documentation of a Cystic Fibrosis (CF) diagnosis as evidenced by 1 or more clinical
features consistent with the CF phenotype and 1 or more of the following criteria:

- Sweat chloride equal to or greater than 60 milliequivalent (mEq/L) by
quantitative pilocarpine iontophoresis test (QPIT)

- 2 well-characterized mutations in the cystic fibrosis transmembrane conductance
regulator (CFTR) gene

- Pancreatic insufficiency documented by having a spot fecal elastase-1 (FE-1) ≤
100μg/g in a stool sample done either historically or at the screening visit

- Clinically stable with no significant changes in health status within 2 weeks prior
to randomization

- FEV1 ≥ 40 and ≤ 100% of predicted for age based on the Wang (males < 18 years,females
< 16 years) or Hankinson (males ≥ 18 years, females ≥ 16 years) standardized
equations at the screening visit

- Weight ≥ 30 kg at the screening visit

- Able to perform repeatable, consistent efforts in pulmonary function testing

- Able to tolerate sputum induction with 3% hypertonic saline and to expectorate with
induction

- Written informed consent (and assent when applicable) obtained from subject or
subject's legal representative

- Ability to swallow softgel capsules

Exclusion Criteria:

- Subjects being treated with ivacaftor (Kalydeco™)

- Liver enzymes aspartate aminotransferase (AST), alanine aminotransferase (ALT), or
gamma-glutamyl transferase (GGT) > 3 times the upper limits of normal at the
screening visit

- Use of antibiotics (oral, iv, and/or inhaled) for acute respiratory symptoms within 2
weeks prior to randomization

- Active treatment for allergic bronchopulmonary aspergillosis (ABPA)

- Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg
prednisone/day or 20 mg prednisone every other day

- Active treatment for nontuberculous mycobacterial (NTM) infection

- Initiation of any new chronic therapy (e.g., ibuprofen, Pulmozyme®, hypertonic
saline,azithromycin,Tobramycin Inhalation solution (TOBI®), Cayston® within 8 weeks
prior to randomization

- Unwilling to discontinue current oral vitamin and antioxidant supplementation
(e.g.,AquADEKs®, another source of β-carotene, vitamin A, vitamin E or
tocopherols,vitamins D or K, n-acetylcysteine, glutathione, CoQ10, other
over-the-counter antioxidant) for the duration of the study

- Use of vitamins (other than control vitamin) or antioxidants within 4 weeks prior to
randomization

- Daily use of > 2 cans of Boost or Pulmocare dietary supplement formulas

- Known hypersensitivity to oral AquADEKs®

- For women of child bearing potential:

1. positive pregnancy test at Visit 1 or at Visit 2, or

2. lactating or

3. unwilling to practice a medically acceptable form of contraception (acceptable
forms of contraception: abstinence, hormonal birth control, intrauterine device,
or barrier method plus a spermicidal agent)

- Subject unlikely to complete the study as determined by the Investigator

- Any condition that the Investigator believes would interfere with the intent of this
study or would make participation not in the best interest of the subject

- Use of investigational therapies within 4 weeks prior to randomization

- Current tobacco smoker

- Current use of anticoagulant medications

- Severe malnutrition based either on having a BMI less than the 5th percentile for
subjects < 18 years of age or a BMI less than 18 kg/m2 for subjects > 18 years of
age.

- Subjects with poorly controlled CF-related diabetes on active insulin therapy,
defined as having a Glycosylated Hemoglobin (HgbA1c) ≥ 7.5% at the most recent
historic evaluation of HgbA1c
We found this trial at
15
sites
5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
11100 Euclid Avenue
Cleveland, Ohio 44106
(216) 844-1000
Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
?
mi
from
Columbus, OH
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
?
mi
from
Hershey, PA
Click here to add this to my saved trials
Madison, Wisconsin 53792
?
mi
from
Madison, WI
Click here to add this to my saved trials
9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Tucson, Arizona 85721
?
mi
from
Tucson, AZ
Click here to add this to my saved trials