Bioavailability of Nutrients Contained in Softgel Capsules vs Tablets
1 other identifier
interventional
15
1 country
1
Brief Summary
This study is a comparison of the bioavailability of nutrients contained in softgel capsules vs tablets.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2010
CompletedFirst Posted
Study publicly available on registry
January 28, 2010
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedFebruary 2, 2012
January 1, 2012
1.6 years
January 27, 2010
January 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bioavailability of nutrients
1 week for each treatment cross-over period
Study Arms (3)
ICAPS AREDS Softgel Capsule - Full Strength
EXPERIMENTALICAPS Eye Vitamin and Mineral Supplement - Softgel
ICAPS AREDS Softgel Capsule - Half Strength
EXPERIMENTALICAPS Eye Vitamin and Mineral Supplement - Softgel (half -strength)
ICAPS AREDS coated tablets - Full Strength
EXPERIMENTALICAPS Eye Vitamin and Mineral Supplement - Coated Tablets
Interventions
Single full strength dose capsule taken one time
Single half strength dose capsule taken one time
Single, full strength dose tablet taken one time
Eligibility Criteria
You may qualify if:
- Age 18 to 35
- Body Mass Index (BMI) 21-27 kg/m2
- Must be able to give written informed consent
- Subjects must be willing to comply with all study requirements.
- Subjects must understand, sign and be given a copy of the written Informed Consent form.
You may not qualify if:
- Subjects who are pregnant, lactating or planning to be pregnant during the course of the study
- Subjects with known sensitivity to planned study concomitant medications
- Subjects participating in any other ophthalmic drug or device clinical trial within 30 days of this clinical investigation.
- Use of ocular drugs, other than study medications, during the study and within 14 days prior to study entry or any other ocular medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, 76134, United States
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2010
First Posted
January 28, 2010
Study Start
February 1, 2010
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
February 2, 2012
Record last verified: 2012-01