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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01859390
• Date of registration: 17/05/2013
• Prospective Registration: Yes
• Primary sponsor: University of Colorado, Denver
• Public title: Effects of an Antioxidant-Enriched Multivitamin Supplement on Inflammation and Oxidative Stress in Cystic Fibrosis AquADEKs-2
• Scientific 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
• Date of first enrolment: June 2013
• Target sample size: 73
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01859390
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Scott Sagel, MD, PhD
• Affiliation: University of Colorado, Denver

Key inclusion & exclusion 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 ß-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



Age minimum: 10 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Dietary Supplement: control multivitamin

Drug: AquADEKs-2

Primary Outcome(s)

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

Secondary Outcome(s)

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

Number of Participants With Pulmonary Exacerbations [Time Frame: Baseline (Visit 2) to end of follow up (Week 18)]

Change in Growth Endpoints [Time Frame: Baseline (Visit 2) to Week 16]

Number of Participants Hospitalized [Time Frame: Baseline (Visit 2) to end of followup (Week 18)]

Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: 18 weeks follow up]

Time to First Pulmonary Exacerbation [Time Frame: Baseline (Visit 2) to end of follow up (Week 18)]

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: 18 weeks follow up]

Number of Pulmonary Exacerbations [Time Frame: Baseline (Visit 2) to end of follow up (Week 18)]

Secondary ID(s)

AQUADEK12K1

13-1557

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Cystic Fibrosis Foundation Therapeutics

Yasoo Health

Results

• Results available: Yes
• Date Posted: 08/06/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01859390