Effects of an Antioxidant-Enriched Multivitamin Supplemen... | NCT01859390

NCT01859390

ID	Type	Description	Link
AQUADEK12K1	Other Identifier	Medic

Status Module

Sponsor/Collaborators Module

Name	Class
Cystic Fibrosis Foundation	OTHER
Yasoo Health	INDUSTRY

Oversight Module

Description Module

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) 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.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AquADEKs-2	Experimental	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 Dietary Supplement: control multivitamin
Control multivitamin	Active Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AquADEKs-2	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Sputum Myeloperoxidase (MPO) Level	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.	Baseline (Visit 2) to Week 16 (Visit 4)

Secondary Outcomes

Measure	Description	Time Frame
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)	Incidence is defined as the number and percentage of participants with at least one event over the 18 week follow-up period.	18 weeks follow up
Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Eligibility Module

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 < 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/Locations Module

Name	Affiliation	Role
Scott Sagel, MD, PhD	University of Colorado, Denver	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center		Tucson	Arizona	85724	United States
Children's Hospital Colorado

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20961818	Background	Sagel SD, Sontag MK, Anthony MM, Emmett P, Papas KA. Effect of an antioxidant-rich multivitamin supplement in cystic fibrosis. J Cyst Fibros. 2011 Jan;10(1):31-6. doi: 10.1016/j.jcf.2010.09.005. Epub 2010 Oct 20.
17569601	Background	Papas KA, Sontag MK, Pardee C, Sokol RJ, Sagel SD, Accurso FJ, Wagener JS. A pilot study on the safety and efficacy of a novel antioxidant rich formulation in patients with cystic fibrosis. J Cyst Fibros. 2008 Jan;7(1):60-7. doi: 10.1016/j.jcf.2007.05.001. Epub 2007 Jun 13.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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. 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. control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

FG00036 subjects
FG00137 subjects

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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. 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. control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.
BG001	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. control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00022.3± 8.9 BG00122.9± 9.5 BG00222.6± 9.1

Age, Customized

Age Category (10-18 years, 18-30 years, 30+ years)

Count of Participants

Participants

Title

Denominators

Categories

Age >=10 - <18 yrs

Title	Measurements
	BG00013 BG00116 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00020 BG00120 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Race/Ethnicity

Title	Measurements
Caucasian	BG00034 BG00130 BG002

Cystic Fibrosis (CF) Genotype

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Delta F508 Homozygous	BG00023 BG00116 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Sputum Myeloperoxidase (MPO) Level

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.

Posted

Mean

Standard Deviation

log10 (ng/mL)

Baseline (Visit 2) to Week 16 (Visit 4)

ID	Title	Description
OG000	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. 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. control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.
OG001	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. control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.

Units	Counts
Participants	OG00035 OG00130

Title

Denominators

Categories

Title	Measurements
	OG000-0.10± 0.67 OG0010.03± 0.76

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Two-sample T-test	t-test, 2 sided		0.460		Mean Difference (Final Values)	-0.13			2-Sided	95	-0.49	0.22					Superiority
OG000 OG001		Regression, Linear

Secondary

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Incidence is defined as the number and percentage of participants with at least one event over the 18 week follow-up period.

Posted

Count of Participants

Participants

18 weeks follow up

ID	Title	Description
OG000	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. 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. control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.
OG001	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. control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.

Secondary

Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Rate is defined as the number of events per participant follow-up week.

Posted

Number

events per participant-week

18 weeks follow up

ID	Title	Description
OG000	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. 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. control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.
OG001	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. control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.

Secondary

Change in Lung Function

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.

This population includes participants who did not complete the study (i.e., did not have a final analyzable sputum sample) but did have a final lung function assessment.

Posted

Mean

Standard Deviation

FEV1 %Predicted

Baseline (Visit 2) to Week 16

ID	Title	Description
OG000	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. 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. control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.
OG001	Control Multivitamin

Secondary

Change in Growth Endpoints

Absolute change in Body Mass Index (BMI) (kg/m^2) between Baseline and Week 16.

This population includes participants who did not complete the study (i.e., did not have a final analyzable sputum sample) but did have final height and weight assessments.

Posted

Mean

Standard Deviation

kg/m^2

Baseline (Visit 2) to Week 16

ID	Title	Description
OG000	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. 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. control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.
OG001	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. control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.

Secondary

Time to First Pulmonary Exacerbation

Median time to first pulmonary exacerbation (PEx) between baseline (Visit 2) and end of follow up (Week 18)

Posted

Median

95% Confidence Interval

days

Baseline (Visit 2) to end of follow up (Week 18)

ID	Title	Description
OG000	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. 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. control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.
OG001	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. control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.

Secondary

Number of Pulmonary Exacerbations

The total number of PEx between baseline (Visit 2) and end of follow up (Week 18).

Posted

Number

Pulmonary Exacerbations

Baseline (Visit 2) to end of follow up (Week 18)

ID	Title	Description
OG000	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. 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. control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.
OG001	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. control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.

Secondary

Number of Participants With Pulmonary Exacerbations

Number (%) with at least one protocol-defined PEx between baseline (Visit 2) and end of follow up (Week 18).

Posted

Count of Participants

Participants

Baseline (Visit 2) to end of follow up (Week 18)

ID	Title	Description
OG000	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. 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. control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.
OG001	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. control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.

Secondary

Number of Participants Hospitalized

Number (%) of participants with at least one hospitalization between Baseline (Visit 2) and end of follow up (Week 18).

Posted

Count of Participants

Participants

Baseline (Visit 2) to end of followup (Week 18)

ID	Title	Description
OG000	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. 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. control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.
OG001	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. control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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. 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. control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.			8	36	33	36
EG001	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. control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.			13	37	34	37

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Palpitations	Cardiac disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected37 at risk
Eye swelling	Eye disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected37 at risk
Asthenia	General disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected37 at risk
Chest discomfort	General disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected37 at risk
Chest pain	General disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected37 at risk
Fatigue	General disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected37 at risk
Pyrexia	General disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected37 at risk
Breath sounds abnormal	Investigations	MedDRA (16.0)	Non-systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected37 at risk
Chest X-ray abnormal	Investigations	MedDRA (16.0)	Non-systematic Assessment	EG0000 events0 affected36 at risk EG0012 events1 affected37 at risk
Forced expiratory volume decreased	Investigations	MedDRA (16.0)	Non-systematic Assessment	EG0002 events2 affected36 at risk EG0011 events1 affected37 at risk
Pulmonary function test decreased	Investigations	MedDRA (16.0)	Non-systematic Assessment	EG0002 events2 affected36 at risk EG0013 events3 affected37 at risk
Weight decreased	Investigations	MedDRA (16.0)	Non-systematic Assessment	EG0001 events1 affected36 at risk EG0012 events2 affected37 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected37 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected37 at risk
Bronchial wall thickening	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected37 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0003 events3 affected36 at risk EG0016 events6 affected37 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0002 events2 affected36 at risk EG0012 events2 affected37 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected37 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 events0 affected36 at risk EG0012 events2 affected37 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected37 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected37 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected37 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected37 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected37 at risk
Sputum increased	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0003 events3 affected36 at risk EG0013 events3 affected37 at risk
Throat tightness	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected37 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected37 at risk
Flushing	Vascular disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected37 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0005 events4 affected36 at risk EG00111 events8 affected37 at risk
Constipation	Gastrointestinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0002 events1 affected36 at risk EG0014 events4 affected37 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0004 events4 affected36 at risk EG0013 events2 affected37 at risk
Flatulence	Gastrointestinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0003 events3 affected36 at risk EG0015 events2 affected37 at risk
Nausea	Gastrointestinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 events0 affected36 at risk EG0012 events2 affected37 at risk
Toothache	Gastrointestinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0002 events2 affected36 at risk EG0010 events0 affected37 at risk
Vomiting	Gastrointestinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0005 events4 affected36 at risk EG0010 events0 affected37 at risk
Asthenia	General disorders	MedDRA (16.0)	Non-systematic Assessment	EG0002 events2 affected36 at risk EG0011 events1 affected37 at risk
Chest pain	General disorders	MedDRA (16.0)	Non-systematic Assessment	EG0000 events0 affected36 at risk EG0012 events2 affected37 at risk
Fatigue	General disorders	MedDRA (16.0)	Non-systematic Assessment	EG0004 events4 affected36 at risk EG0017 events5 affected37 at risk
Pyrexia	General disorders	MedDRA (16.0)	Non-systematic Assessment	EG0002 events2 affected36 at risk EG0016 events5 affected37 at risk
Pharyngitis	Infections and infestations	MedDRA (16.0)	Non-systematic Assessment	EG0002 events2 affected36 at risk EG0010 events0 affected37 at risk
Forced expiratory volume decreased	Investigations	MedDRA (16.0)	Non-systematic Assessment	EG0003 events2 affected36 at risk EG0011 events1 affected37 at risk
Pseudomonas test positive	Investigations	MedDRA (16.0)	Non-systematic Assessment	EG0000 events0 affected36 at risk EG0012 events2 affected37 at risk
Pulmonary function test decreased	Investigations	MedDRA (16.0)	Non-systematic Assessment	EG0009 events6 affected36 at risk EG00110 events9 affected37 at risk
Weight decreased	Investigations	MedDRA (16.0)	Non-systematic Assessment	EG0003 events3 affected36 at risk EG0013 events3 affected37 at risk
Headache	Nervous system disorders	MedDRA (16.0)	Non-systematic Assessment	EG0007 events4 affected36 at risk EG0015 events5 affected37 at risk
Sinus headache	Nervous system disorders	MedDRA (16.0)	Non-systematic Assessment	EG0002 events2 affected36 at risk EG0011 events1 affected37 at risk
Anxiety	Psychiatric disorders	MedDRA (16.0)	Non-systematic Assessment	EG0002 events2 affected36 at risk EG0010 events0 affected37 at risk
Decreased activity	Psychiatric disorders	MedDRA (16.0)	Non-systematic Assessment	EG0002 events2 affected36 at risk EG0011 events1 affected37 at risk
Depression	Psychiatric disorders	MedDRA (16.0)	Non-systematic Assessment	EG0001 events1 affected36 at risk EG0013 events3 affected37 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG00030 events22 affected36 at risk EG00130 events19 affected37 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0005 events4 affected36 at risk EG0018 events8 affected37 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0004 events4 affected36 at risk EG0016 events5 affected37 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG00011 events7 affected36 at risk EG0018 events8 affected37 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0006 events4 affected36 at risk EG0011 events1 affected37 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0004 events3 affected36 at risk EG0018 events7 affected37 at risk
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0004 events4 affected36 at risk EG0018 events8 affected37 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0005 events4 affected36 at risk EG0015 events4 affected37 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0004 events4 affected36 at risk EG0013 events3 affected37 at risk
Sputum discoloured	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0003 events3 affected36 at risk EG0012 events1 affected37 at risk
Sputum increased	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG00014 events11 affected36 at risk EG00112 events10 affected37 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (16.0)	Non-systematic Assessment	EG0002 events2 affected36 at risk EG0011 events1 affected37 at risk

We did not meet the complete enrollment of 80 subjects due to the expiration dates of the antioxidant-enriched and control multivitamins produced for the study.

Certain Agreements

ID	Term
D003550	Cystic Fibrosis
D007249	Inflammation

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D007232	Infant, Newborn, Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

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.

control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.