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

NCT01018303 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2012-10-15

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

AquADEK

Two AquADEK softgel vitamins on a daily basis x 12 weeks

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • Yasoo Health

    collaborator INDUSTRY

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Scott D Sagel, MD · University of Colorado, Denver

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-06-30
Completion
2009-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01018303 on ClinicalTrials.gov