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

October 11, 2012 updated by: University of Colorado, Denver

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • The Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 40 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma levels of beta-carotene
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma levels of coenzyme Q10, retinol (Vitamin A), 25-hydroxy vitamin D, alpha- and gamma-tocopherols (Vitamin E), PIVKA-II
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Institutes of Health (NIH)
Cystic Fibrosis Foundation
Yasoo Health

Investigators

  • Principal Investigator: Scott D Sagel, MD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

November 19, 2009

First Submitted That Met QC Criteria

November 20, 2009

First Posted (Estimate)

November 23, 2009

Study Record Updates

Last Update Posted (Estimate)

October 15, 2012

Last Update Submitted That Met QC Criteria

October 11, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-0355

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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