Bioavailability of Nutrients Contained in Softgel Capsules vs Tablets

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT01057966

First received: January 27, 2010

Last updated: January 31, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 27, 2010
Last Updated Date	January 31, 2012
Start Date ^ICMJE	February 2010
Primary Completion Date	September 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 27, 2010)	Bioavailability of nutrients [ Time Frame: 1 week for each treatment cross-over period ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01057966 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Bioavailability of Nutrients Contained in Softgel Capsules vs Tablets
Official Title ^ICMJE	Not Provided
Brief Summary	This study is a comparison of the bioavailability of nutrients contained in softgel capsules vs tablets.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Supportive Care
Condition ^ICMJE	Vision
Intervention ^ICMJE	Dietary Supplement: ICAPS Eye Vitamin and Mineral Supplement - Softgel (full strength) Single full strength dose capsule taken one time Dietary Supplement: ICAPS Eye Vitamin and Mineral Supplement - Softgel (half strength) Single half strength dose capsule taken one time Dietary Supplement: ICAPS Eye Vitamin and Mineral Supplement - Coated Tablets (full strength) Single, full strength dose tablet taken one time
Study Arm (s)	Experimental: ICAPS AREDS Softgel Capsule - Full Strength ICAPS Eye Vitamin and Mineral Supplement - Softgel Intervention: Dietary Supplement: ICAPS Eye Vitamin and Mineral Supplement - Softgel (full strength) Experimental: ICAPS AREDS Softgel Capsule - Half Strength ICAPS Eye Vitamin and Mineral Supplement - Softgel (half -strength) Intervention: Dietary Supplement: ICAPS Eye Vitamin and Mineral Supplement - Softgel (half strength) Experimental: ICAPS AREDS coated tablets - Full Strength ICAPS Eye Vitamin and Mineral Supplement - Coated Tablets Intervention: Dietary Supplement: ICAPS Eye Vitamin and Mineral Supplement - Coated Tablets (full strength)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	15
Completion Date	September 2011
Primary Completion Date	September 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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. Exclusion Criteria: Subjects for whom both eyes do not meet all inclusion criteria and either eye meets exclusion criteria 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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01057966
Other Study ID Numbers ^ICMJE	SMA-09-32
Has Data Monitoring Committee	No
Responsible Party	Alcon Research
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top