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

November 19, 2009
October 11, 2012
August 2007
June 2008   (final data collection date for primary outcome measure)
Plasma levels of beta-carotene [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01018303 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of an Antioxidant-rich Multivitamin Supplement in Cystic Fibrosis
Safety and Efficacy of a Novel Antioxidant-rich Multivitamin Supplement for Persons With Cystic Fibrosis

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.

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.
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cystic Fibrosis
Dietary Supplement: AquADEK
Two AquADEK softgel vitamins on a daily basis x 12 weeks
Experimental: Antioxidant-enriched multivitamin supplement
Intervention: Dietary Supplement: AquADEK
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. Epub 2010 Oct 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
November 2009
June 2008   (final data collection date for primary outcome measure)

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
Both
10 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01018303
07-0355
No
University of Colorado, Denver
University of Colorado, Denver
  • Cystic Fibrosis Foundation
  • Yasoo Health
  • National Institutes of Health (NIH)
Principal Investigator: Scott D Sagel, MD University of Colorado, Denver
University of Colorado, Denver
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP