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

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Antioxidants, Vitamins, Inflammation, Oxidative stress Read More

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