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

This study has been completed.
Sponsor:
Collaborators:
Cystic Fibrosis Foundation
Yasoo Health
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01018303
First received: November 19, 2009
Last updated: October 11, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Cystic Fibrosis
Dietary Supplement: AquADEK
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of a Novel Antioxidant-rich Multivitamin Supplement for Persons With Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Plasma levels of beta-carotene [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma levels of coenzyme Q10, retinol (Vitamin A), 25-hydroxy vitamin D, alpha- and gamma-tocopherols (Vitamin E), PIVKA-II [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: August 2007
Study Completion Date: November 2009
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antioxidant-enriched multivitamin supplement Dietary Supplement: AquADEK
Two AquADEK softgel vitamins on a daily basis x 12 weeks

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.

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.
  Eligibility

Ages Eligible for Study:   10 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018303

Locations
United States, Colorado
The Children's Hospital
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Cystic Fibrosis Foundation
Yasoo Health
Investigators
Principal Investigator: Scott D Sagel, MD University of Colorado, Denver
  More Information

Publications:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01018303     History of Changes
Other Study ID Numbers: 07-0355
Study First Received: November 19, 2009
Last Updated: October 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
cystic fibrosis
vitamins
antioxidants
anthropometric measurements
pulmonary function

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014