Safety and Efficacy of an Antioxidant-rich Multivitamin Supplement in Cystic Fibrosis

Sponsor

University of Colorado, Denver (Other)

Overall Status

Completed

CT.gov ID

NCT01018303

Collaborator

Cystic Fibrosis Foundation (Other), Yasoo Health (Industry), National Institutes of Health (NIH) (NIH)

Enrollment

Location

Arm

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to test the safety and efficacy of the final commercial formulation of an antioxidant enriched multivitamin supplement in softgel capsule form (AquADEKs) in increasing the plasma levels of certain nutrients and antioxidants in individuals with cystic fibrosis.

Hypothesis: An oral antioxidant-rich multivitamin supplement (AquADEKs), which uses a Generally Regarded As Safe (GRAS) molecule to form micelle-like vehicles, will safely increase systemic levels of beta-carotene, coenzyme Q10, and gamma-tocopherol, decrease PIVKA-II levels, while maintaining levels of vitamins A and D in the normal range in persons with CF > 10 years of age.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Dietary Supplement: AquADEK	Phase 1/Phase 2

Detailed Description

In cystic fibrosis (CF), pancreatic insufficiency and a diminished bile acid pool cause malabsorption of important nutrients and dietary components leading to poor nutritional status and oxidative stress. Of particular significance is the malabsorption of fat-soluble nutrients, such as vitamins A, D, E and K which are critical for normal metabolic functions. Furthermore this malabsorption prevents individuals with CF from adequately absorbing and maintaining levels of lipophilic nutrients and antioxidants such as beta-carotene, coenzyme Q10 (CoQ10) and gamma-tocopherol which may provide benefits when supplied at levels higher than those obtained from normal diets. Current standard of care supplementation often does not normalize the blood levels of certain vitamins and antioxidants.

An oral formulation, which can form micelle-like vehicles, can be used to overcome the malabsorption of these nutrients in CF patients. A pilot study of a prototype formulation showed both safety and efficacy in increasing systemic levels of target nutrients. This study will test the safety and efficacy of the final commercial formulation (AquADEKs) in the form of a softgel capsule in increasing the plasma levels of certain nutrients and antioxidants.

Specific Aims:

To evaluate the safety of AquADEKs by monitoring patient reported symptoms and adverse events, and following vitamin and antioxidant levels, particularly vitamin A, to ensure that they do not exceed normative ranges after supplementation.
To determine the efficacy of AquADEKs in increasing the antioxidants beta-carotene, CoQ10, and γ-tocopherol and maintaining plasma levels of vitamins A, D, α-tocopherol and PIVKA-II (surrogate of vitamin K status) in the normal range.

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Safety and Efficacy of a Novel Antioxidant-rich Multivitamin Supplement for Persons With Cystic Fibrosis

Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Antioxidant-enriched multivitamin supplement	Dietary Supplement: AquADEK Two AquADEK softgel vitamins on a daily basis x 12 weeks

Arm

Intervention/Treatment

Experimental: Antioxidant-enriched multivitamin supplement

Dietary Supplement: AquADEK

Two AquADEK softgel vitamins on a daily basis x 12 weeks

Outcome Measures

Primary Outcome Measures

Plasma levels of beta-carotene [12 weeks]

Secondary Outcome Measures

Plasma levels of coenzyme Q10, retinol (Vitamin A), 25-hydroxy vitamin D, alpha- and gamma-tocopherols (Vitamin E), PIVKA-II [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of CF as evidenced by a sweat chloride test > 60mEq/L or by the presence of two known CF mutations
Male or female, ages between 10-40 years old
30 kg body weight
FEV1 > 35% predicted for age and height
Clinically stable with no recent hospitalization within the past 2 weeks

Exclusion Criteria:

Significant liver disease as defined by clinical findings of portal hypertension or cirrhosis or AST, ALT, or GGT >2x upper limits of normal within the previous 6 months
Poor compliance with medical regimen as assessed by CF clinic care providers
Oral supplementation with AquADEKs or another source of beta-carotene or CoQ10 in the 2 months prior to the study
Pregnant or lactating
Participation in another interventional clinical trial within the previous 2 weeks
Difficulty swallowing softgels