Status:
COMPLETED
Effects of an Antioxidant-Enriched Multivitamin Supplement on Inflammation and Oxidative Stress in Cystic Fibrosis
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Cystic Fibrosis Foundation
Yasoo Health
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
10+ years
Phase:
PHASE2
Brief 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) ...
Eligibility Criteria
Inclusion
- 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
- 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:
- positive pregnancy test at Visit 1 or at Visit 2, or
- lactating or
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01859390
Start Date
June 1 2013
End Date
July 1 2016
Last Update
July 14 2017
Active Locations (15)
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1
University Medical Center
Tucson, Arizona, United States, 85724
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
3
The Nemours Children's Clinic
Orlando, Florida, United States, 32806
4
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201