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NCT01018303 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of an Antioxidant-rich Multivitamin Supplement in Cystic Fibrosis
A Phase 1 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT01018303 is a Phase 1 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 17 participants.
The verdict
NCT01018303, a Phase 1 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
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.
Interventions
- DIETARY_SUPPLEMENT AquADEK
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2007-08 |
| Est. Completion | 2009-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01018303
The ClinicalTrials.gov registry entry for NCT01018303 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AquADEK is the first listed.
NCT01018303 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01018303 about?
NCT01018303 is a clinical study titled "Safety and Efficacy of an Antioxidant-rich Multivitamin Supplement in 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. Hypothesi...
What is the current status of trial NCT01018303?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2007-08. Estimated completion is 2009-11.
What interventions are being tested in trial NCT01018303?
The interventions under investigation include: AquADEK (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01018303?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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