Safety and Efficacy of an Antioxidant-rich Multivitamin Supplement in Cystic Fibrosis
Completed · Phase 1/Phase 2
Conditions studied: Cystic Fibrosis
In brief
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.
Key facts
- Study ID
- NCT01018303
- Run by
- University of Colorado, Denver
- People needed
- 17
- Starts
- 2007-08-01
- Expected to finish
- 2009-11-01
- Last updated by the study team
- 2012-10-15
Who can join
Age: 10 and older, up to 40. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The Children's Hospital — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
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