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Effects of an Antioxidant-Enriched Multivitamin Supplement on Inflammation and Oxidative Stress in Cystic Fibrosis (AquADEKs-2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01859390
First Posted: May 21, 2013
Last Update Posted: July 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Cystic Fibrosis Foundation Therapeutics
Yasoo Health
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis Drug: AquADEKs-2 Dietary Supplement: control multivitamin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Change in Sputum Myeloperoxidase (MPO) Level [ Time Frame: Baseline (Visit 2) to Week 16 (Visit 4) ]
    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.


Secondary Outcome Measures:
  • Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 18 weeks follow up ]
    Incidence is defined as the number and percentage of participants with at least one event over the 18 week follow-up period.

  • Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 18 weeks follow up ]
    Rate is defined as the number of events per participant follow-up week.

  • Change in Lung Function [ Time Frame: Baseline (Visit 2) to Week 16 ]
    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.

  • Change in Growth Endpoints [ Time Frame: Baseline (Visit 2) to Week 16 ]
    Absolute change in Body Mass Index (BMI) (kg/m^2) between Baseline and Week 16.

  • Time to First Pulmonary Exacerbation [ Time Frame: Baseline (Visit 2) to end of follow up (Week 18) ]
    Median time to first pulmonary exacerbation (PEx) between baseline (Visit 2) and end of follow up (Week 18)

  • Number of Pulmonary Exacerbations [ Time Frame: Baseline (Visit 2) to end of follow up (Week 18) ]
    The total number of PEx between baseline (Visit 2) and end of follow up (Week 18).

  • Number of Participants With Pulmonary Exacerbations [ Time Frame: Baseline (Visit 2) to end of follow up (Week 18) ]
    Number (%) with at least one protocol-defined PEx between baseline (Visit 2) and end of follow up (Week 18).

  • Number of Participants Hospitalized [ Time Frame: Baseline (Visit 2) to end of followup (Week 18) ]
    Number (%) of participants with at least one hospitalization between Baseline (Visit 2) and end of follow up (Week 18).


Enrollment: 73
Study Start Date: June 2013
Study Completion Date: July 2016
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AquADEKs-2
Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.
Drug: AquADEKs-2
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.
Other Name: Antioxidant-enriched multivitamin supplement
Dietary Supplement: control multivitamin
The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.
Active Comparator: Control multivitamin
Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.
Dietary Supplement: control multivitamin
The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Forced expiratory volume over one second (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 body mass index (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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01859390


Locations
United States, Arizona
University Medical Center
Tucson, Arizona, United States, 85724
United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
United States, Florida
The Nemours Children's Clinic
Orlando, Florida, United States, 32806
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Minnesota
University of Minnesota Children's Hospital
Minneapolis, Minnesota, United States, 55455
United States, New York
Women and Children's Hospital of Buffalo
Buffalo, New York, United States, 14222
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-5735
United States, Texas
The University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
United States, Wisconsin
University of Wisconsin Hospital Center
Madison, Wisconsin, United States, 53792
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
University of Colorado, Denver
Cystic Fibrosis Foundation Therapeutics
Yasoo Health
Investigators
Principal Investigator: Scott Sagel, MD, PhD University of Colorado, Denver
  More Information

Publications:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01859390     History of Changes
Other Study ID Numbers: 13-1557
AQUADEK12K1 ( Other Identifier: Medic )
First Submitted: May 17, 2013
First Posted: May 21, 2013
Results First Submitted: March 10, 2017
Results First Posted: June 8, 2017
Last Update Posted: July 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Colorado, Denver:
Antioxidants
Vitamins
Inflammation
Oxidative stress

Additional relevant MeSH terms:
Fibrosis
Inflammation
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Vitamins
Antioxidants
Micronutrients
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents