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

2014-08-27 03:17:49 | BioPortfolio

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.

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.

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.

Specific Aims:

1. 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.

2. 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

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Cystic Fibrosis

Intervention

AquADEK

Location

The Children's Hospital
Aurora
Colorado
United States
80045

Status

Completed

Source

University of Colorado, Denver

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:49-0400

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An autosomal recessive genetic disease of the EXOCRINE GLANDS. It is caused by mutations in the gene encoding the CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR expressed in several organs including the LUNG, the PANCREAS, the BILIARY SYSTEM, and the SWEAT GLANDS. Cystic fibrosis is characterized by epithelial secretory dysfunction associated with ductal obstruction resulting in AIRWAY OBSTRUCTION; chronic RESPIRATORY INFECTIONS; PANCREATIC INSUFFICIENCY; maldigestion; salt depletion; and HEAT PROSTRATION.

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