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Trial record 1 of 1 for:    NCT01859390
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Effects of an Antioxidant-Enriched Multivitamin Supplement on Inflammation and Oxidative Stress in Cystic Fibrosis (AquADEKs-2)

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ClinicalTrials.gov Identifier: NCT01859390
Recruitment Status : Completed
First Posted : May 21, 2013
Results First Posted : June 8, 2017
Last Update Posted : July 14, 2017
Sponsor:
Collaborators:
Cystic Fibrosis Foundation
Yasoo Health
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cystic Fibrosis
Interventions Drug: AquADEKs-2
Dietary Supplement: control multivitamin
Enrollment 73
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AquADEKs-2 Control Multivitamin
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started [1] 36 37
Withdrawals [2] 2 2
Completed [3] 35 30
Not Completed 1 7
Reason Not Completed
Insufficient Sputum Collected             1             3
Sample Missing Collection Date             0             1
Tube Cracked             0             2
Shipment Error             0             1
[1]
Randomized
[2]
Participants can withdraw anytime prior to their Week 18 follow-up visit.
[3]
Based on availability of Week 16 sputum myeloperoxidase (MPO) measurement (primary endpoint)
Arm/Group Title AquADEKs-2 Control Multivitamin Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 36 37 73
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 37 participants 73 participants
22.3  (8.9) 22.9  (9.5) 22.6  (9.1)
Age, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 37 participants 73 participants
Age >=10 - <18 yrs
13
  36.1%
16
  43.2%
29
  39.7%
Age >=18 - <30 yrs
17
  47.2%
11
  29.7%
28
  38.4%
Age >30 yrs
6
  16.7%
10
  27.0%
16
  21.9%
[1]
Measure Description: Age Category (10-18 years, 18-30 years, 30+ years)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 37 participants 73 participants
Female
20
  55.6%
20
  54.1%
40
  54.8%
Male
16
  44.4%
17
  45.9%
33
  45.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race/Ethnicity Number Analyzed 36 participants 37 participants 73 participants
Caucasian
34
  94.4%
30
  81.1%
64
  87.7%
Hispanic
1
   2.8%
5
  13.5%
6
   8.2%
African-American
1
   2.8%
1
   2.7%
2
   2.7%
Unknown/Other
0
   0.0%
1
   2.7%
1
   1.4%
Cystic Fibrosis (CF) Genotype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 37 participants 73 participants
Delta F508 Homozygous
23
  63.9%
16
  43.2%
39
  53.4%
Delta F508 Heterozygous
9
  25.0%
18
  48.6%
27
  37.0%
Other
3
   8.3%
3
   8.1%
6
   8.2%
Not Identified
1
   2.8%
0
   0.0%
1
   1.4%
1.Primary Outcome
Title Change in Sputum Myeloperoxidase (MPO) Level
Hide Description 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.
Time Frame Baseline (Visit 2) to Week 16 (Visit 4)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AquADEKs-2 Control Multivitamin
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 35 30
Mean (Standard Deviation)
Unit of Measure: log10 (ng/mL)
-0.10  (0.67) 0.03  (0.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AquADEKs-2, Control Multivitamin
Comments Two-sample T-test
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.460
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.13
Confidence Interval (2-Sided) 95%
-0.49 to 0.22
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AquADEKs-2, Control Multivitamin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.325
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.170
Confidence Interval (2-Sided) 95%
-0.513 to 0.173
Estimation Comments

Regression Model predictors include: AquADEKs-2 arm, Age >=18 years, Sex, Screening FEV1%Predicted >70%, Chronic use of Inhaled Antibiotics and Azithromycin.

The estimated value is the mean difference between groups for 16 week change in log10 MPO.

2.Secondary Outcome
Title Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description Incidence is defined as the number and percentage of participants with at least one event over the 18 week follow-up period.
Time Frame 18 weeks follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AquADEKs-2 Control Multivitamin
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 36 37
Measure Type: Count of Participants
Unit of Measure: Participants
Incidence of AEs
33
  91.7%
34
  91.9%
Incidence of SAEs
8
  22.2%
13
  35.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AquADEKs-2, Control Multivitamin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.302
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportions-SAE incidence
Estimated Value -12.9
Confidence Interval (2-Sided) 95%
-32.1 to 7.8
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description Rate is defined as the number of events per participant follow-up week.
Time Frame 18 weeks follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AquADEKs-2 Control Multivitamin
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 36 37
Measure Type: Number
Unit of Measure: events per participant-week
Number of AEs per participant week 0.34 0.37
Number of SAEs per participant week 0.04 0.05
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AquADEKs-2, Control Multivitamin
Comments Rate Ratio for Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the AquADEKs-2 group was 642 and in the Control group was 639.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.486
Comments [Not Specified]
Method Poisson Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.78 to 1.13
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection AquADEKs-2, Control Multivitamin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Rate Ratio for Serious Adverse Events calculated using Poisson Regression with an offset for the log of follow-up time in weeks. The total number of follow-up weeks in the AquADEKs-2 group was 642 and in the Control group was 639.
Statistical Test of Hypothesis P-Value 0.269
Comments [Not Specified]
Method Poisson Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.43 to 1.26
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Lung Function
Hide Description 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.
Time Frame Baseline (Visit 2) to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AquADEKs-2 Control Multivitamin
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 34 35
Mean (Standard Deviation)
Unit of Measure: FEV1 %Predicted
-0.76  (8.00) -2.20  (7.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Multivitamin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Two sample T-test
Statistical Test of Hypothesis P-Value 0.4463
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 1.43
Confidence Interval (2-Sided) 95%
-2.30 to 5.16
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Growth Endpoints
Hide Description Absolute change in Body Mass Index (BMI) (kg/m^2) between Baseline and Week 16.
Time Frame Baseline (Visit 2) to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AquADEKs-2 Control Multivitamin
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 34 34
Mean (Standard Deviation)
Unit of Measure: kg/m^2
0.16  (0.68) 0.13  (0.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AquADEKs-2, Control Multivitamin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8623
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.37 to 0.44
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Time to First Pulmonary Exacerbation
Hide Description Median time to first pulmonary exacerbation (PEx) between baseline (Visit 2) and end of follow up (Week 18)
Time Frame Baseline (Visit 2) to end of follow up (Week 18)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AquADEKs-2 Control Multivitamin
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 36 37
Median (95% Confidence Interval)
Unit of Measure: days
102 [1] 
(78 to NA)
96
(35 to 125)
[1]
The upper bound of the confidence interval could not be computed due to the distribution of events in the AquADEKs-2 arm.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AquADEKs-2, Control Multivitamin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0534
Comments Not adjusted for multiple comparisons. Alpha at 0.05.
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.536
Confidence Interval (2-Sided) 95%
0.284 to 1.009
Estimation Comments

Cox model parameters include: AquADEKs-2 arm, Age >=18 years, Sex, Screening FEV1 % Predicted >70%, Chronic use of Inhaled Antibiotics and Azithromycin.

The parameter of interest is the Hazard Ratio comparing the AquADEKs-2 arm to the control arm.

7.Secondary Outcome
Title Number of Pulmonary Exacerbations
Hide Description The total number of PEx between baseline (Visit 2) and end of follow up (Week 18).
Time Frame Baseline (Visit 2) to end of follow up (Week 18)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AquADEKs-2 Control Multivitamin
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 36 37
Measure Type: Number
Unit of Measure: Pulmonary Exacerbations
28 39
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AquADEKs-2, Control Multivitamin
Comments Rate Ratio for PEx calculated using Poisson Regression with an offset for the log of follow-up time in months. The total number of follow-up months in the AquADEKs-2 group was 148 and in the Control group was 147.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1731
Comments [Not Specified]
Method Poisson Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
0.44 to 1.16
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Participants With Pulmonary Exacerbations
Hide Description Number (%) with at least one protocol-defined PEx between baseline (Visit 2) and end of follow up (Week 18).
Time Frame Baseline (Visit 2) to end of follow up (Week 18)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AquADEKs-2 Control Multivitamin
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 36 37
Measure Type: Count of Participants
Unit of Measure: Participants
19
  52.8%
25
  67.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AquADEKs-2, Control Multivitamin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Difference in Proportions
Statistical Test of Hypothesis P-Value 0.2363
Comments Not adjusted for multiple comparisons. Alpha at 0.05.
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -14.8
Confidence Interval (2-Sided) 95%
-35.1 to 7.4
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Number of Participants Hospitalized
Hide Description Number (%) of participants with at least one hospitalization between Baseline (Visit 2) and end of follow up (Week 18).
Time Frame Baseline (Visit 2) to end of followup (Week 18)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AquADEKs-2 Control Multivitamin
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 36 37
Measure Type: Count of Participants
Unit of Measure: Participants
7
  19.4%
13
  35.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Multivitamin
Comments [Not Specified]
Type of Statistical Test Superiority
Comments Difference in Proportions
Statistical Test of Hypothesis P-Value 0.1900
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -15.7
Confidence Interval (2-Sided) 95%
-34.5 to 4.8
Estimation Comments [Not Specified]
Time Frame Participant adverse event data was collected for the 4 months that subjects were on study drug.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AquADEKs-2 Control Multivitamin
Hide Arm/Group Description

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.

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.

All-Cause Mortality
AquADEKs-2 Control Multivitamin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
AquADEKs-2 Control Multivitamin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/36 (22.22%)      13/37 (35.14%)    
Cardiac disorders     
Palpitations * 1  1/36 (2.78%)  1 0/37 (0.00%)  0
Eye disorders     
Eye swelling * 1  1/36 (2.78%)  1 0/37 (0.00%)  0
General disorders     
Asthenia * 1  0/36 (0.00%)  0 1/37 (2.70%)  1
Chest discomfort * 1  0/36 (0.00%)  0 1/37 (2.70%)  1
Chest pain * 1  1/36 (2.78%)  1 0/37 (0.00%)  0
Fatigue * 1  1/36 (2.78%)  1 0/37 (0.00%)  0
Pyrexia * 1  0/36 (0.00%)  0 1/37 (2.70%)  1
Investigations     
Breath sounds abnormal * 1  0/36 (0.00%)  0 1/37 (2.70%)  1
Chest X-ray abnormal * 1  0/36 (0.00%)  0 1/37 (2.70%)  2
Forced expiratory volume decreased * 1  2/36 (5.56%)  2 1/37 (2.70%)  1
Pulmonary function test decreased * 1  2/36 (5.56%)  2 3/37 (8.11%)  3
Weight decreased * 1  1/36 (2.78%)  1 2/37 (5.41%)  2
Musculoskeletal and connective tissue disorders     
Musculoskeletal chest pain * 1  0/36 (0.00%)  0 1/37 (2.70%)  1
Renal and urinary disorders     
Nephrolithiasis * 1  1/36 (2.78%)  1 0/37 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Bronchial wall thickening * 1  1/36 (2.78%)  1 0/37 (0.00%)  0
Cough * 1  3/36 (8.33%)  3 6/37 (16.22%)  6
Dyspnoea * 1  2/36 (5.56%)  2 2/37 (5.41%)  2
Dyspnoea exertional * 1  1/36 (2.78%)  1 0/37 (0.00%)  0
Haemoptysis * 1  0/36 (0.00%)  0 2/37 (5.41%)  2
Hypoxia * 1  0/36 (0.00%)  0 1/37 (2.70%)  1
Nasal congestion * 1  0/36 (0.00%)  0 1/37 (2.70%)  1
Pneumothorax * 1  0/36 (0.00%)  0 1/37 (2.70%)  1
Respiratory distress * 1  0/36 (0.00%)  0 1/37 (2.70%)  1
Respiratory tract congestion * 1  0/36 (0.00%)  0 1/37 (2.70%)  1
Sputum increased * 1  3/36 (8.33%)  3 3/37 (8.11%)  3
Throat tightness * 1  1/36 (2.78%)  1 0/37 (0.00%)  0
Skin and subcutaneous tissue disorders     
Swelling face * 1  1/36 (2.78%)  1 0/37 (0.00%)  0
Vascular disorders     
Flushing * 1  1/36 (2.78%)  1 0/37 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AquADEKs-2 Control Multivitamin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/36 (91.67%)      34/37 (91.89%)    
Gastrointestinal disorders     
Abdominal pain * 1  4/36 (11.11%)  5 8/37 (21.62%)  11
Constipation * 1  1/36 (2.78%)  2 4/37 (10.81%)  4
Diarrhoea * 1  4/36 (11.11%)  4 2/37 (5.41%)  3
Flatulence * 1  3/36 (8.33%)  3 2/37 (5.41%)  5
Nausea * 1  0/36 (0.00%)  0 2/37 (5.41%)  2
Toothache * 1  2/36 (5.56%)  2 0/37 (0.00%)  0
Vomiting * 1  4/36 (11.11%)  5 0/37 (0.00%)  0
General disorders     
Asthenia * 1  2/36 (5.56%)  2 1/37 (2.70%)  1
Chest pain * 1  0/36 (0.00%)  0 2/37 (5.41%)  2
Fatigue * 1  4/36 (11.11%)  4 5/37 (13.51%)  7
Pyrexia * 1  2/36 (5.56%)  2 5/37 (13.51%)  6
Infections and infestations     
Pharyngitis * 1  2/36 (5.56%)  2 0/37 (0.00%)  0
Investigations     
Forced expiratory volume decreased * 1  2/36 (5.56%)  3 1/37 (2.70%)  1
Pseudomonas test positive * 1  0/36 (0.00%)  0 2/37 (5.41%)  2
Pulmonary function test decreased * 1  6/36 (16.67%)  9 9/37 (24.32%)  10
Weight decreased * 1  3/36 (8.33%)  3 3/37 (8.11%)  3
Nervous system disorders     
Headache * 1  4/36 (11.11%)  7 5/37 (13.51%)  5
Sinus headache * 1  2/36 (5.56%)  2 1/37 (2.70%)  1
Psychiatric disorders     
Anxiety * 1  2/36 (5.56%)  2 0/37 (0.00%)  0
Decreased activity * 1  2/36 (5.56%)  2 1/37 (2.70%)  1
Depression * 1  1/36 (2.78%)  1 3/37 (8.11%)  3
Respiratory, thoracic and mediastinal disorders     
Cough * 1  22/36 (61.11%)  30 19/37 (51.35%)  30
Dyspnoea * 1  4/36 (11.11%)  5 8/37 (21.62%)  8
Haemoptysis * 1  4/36 (11.11%)  4 5/37 (13.51%)  6
Nasal congestion * 1  7/36 (19.44%)  11 8/37 (21.62%)  8
Oropharyngeal pain * 1  4/36 (11.11%)  6 1/37 (2.70%)  1
Rales * 1  3/36 (8.33%)  4 7/37 (18.92%)  8
Respiratory tract congestion * 1  4/36 (11.11%)  4 8/37 (21.62%)  8
Rhinorrhoea * 1  4/36 (11.11%)  5 4/37 (10.81%)  5
Sinus congestion * 1  4/36 (11.11%)  4 3/37 (8.11%)  3
Sputum discoloured * 1  3/36 (8.33%)  3 1/37 (2.70%)  2
Sputum increased * 1  11/36 (30.56%)  14 10/37 (27.03%)  12
Wheezing * 1  2/36 (5.56%)  2 1/37 (2.70%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (16.0)
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
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Scott Sagel, Professor of Pediatrics
Organization: University of Colorado School of Medicine
Phone: 720-777-2522
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01859390     History of Changes
Other Study ID Numbers: 13-1557
AQUADEK12K1 ( Other Identifier: Medic )
First Submitted: May 17, 2013
First Posted: May 21, 2013
Results First Submitted: March 10, 2017
Results First Posted: June 8, 2017
Last Update Posted: July 14, 2017