Phase 2 N=73 Randomized Quadruple-blind Treatment

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

Cystic Fibrosis

Bottom Line

View on ClinicalTrials.gov: NCT01859390 ↗

Enrolled (actual)

Serious AEs

28.8%

Results posted

Jun 2017

Primary outcome: Primary: Change in Sputum Myeloperoxidase (MPO) Level — -0.10; 0.03 log10 (ng/mL) — p=0.460

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AquADEKs-2 (Drug); control multivitamin (Dietary_supplement)
Age: Pediatric, Adult, Older Adult · 10+ yrs
Sex: All
Sponsor: University of Colorado, Denver
Primary completion: Apr 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Sputum Myeloperoxidase (MPO) Level	-0.10; 0.03	0.460
SECONDARY Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)	33; 34; 8; 13	0.302
SECONDARY Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)	0.34; 0.37; 0.04; 0.05	0.486
SECONDARY Change in Lung Function	-0.76; -2.20	0.4463
SECONDARY Change in Growth Endpoints	0.16; 0.13	0.8623
SECONDARY Time to First Pulmonary Exacerbation	102; 96	0.0534
SECONDARY Number of Pulmonary Exacerbations	28; 39	0.1731
SECONDARY Number of Participants With Pulmonary Exacerbations	19; 25	0.2363
SECONDARY Number of Participants Hospitalized	7; 13	0.1900

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) 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.

Eligibility 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 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.
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

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Data sourced from ClinicalTrials.gov (NCT01859390). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.