Bioavailability of Nutrients Contained in Softgel Capsules vs Tablets

January 31, 2012 updated by: Alcon Research
This study is a comparison of the bioavailability of nutrients contained in softgel capsules vs tablets.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76134
        • Contact Alcon Call Center for Trial Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18 to 35
  2. Body Mass Index (BMI) 21-27 kg/m2
  3. Must be able to give written informed consent
  4. Subjects must be willing to comply with all study requirements.
  5. Subjects must understand, sign and be given a copy of the written Informed Consent form.

Exclusion Criteria:

  1. Subjects for whom both eyes do not meet all inclusion criteria and either eye meets exclusion criteria
  2. Subjects who are pregnant, lactating or planning to be pregnant during the course of the study
  3. Subjects with known sensitivity to planned study concomitant medications
  4. Subjects participating in any other ophthalmic drug or device clinical trial within 30 days of this clinical investigation.
  5. Use of ocular drugs, other than study medications, during the study and within 14 days prior to study entry or any other ocular medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICAPS AREDS Softgel Capsule - Full Strength
ICAPS Eye Vitamin and Mineral Supplement - Softgel
Dietary supplement: ICAPS Eye Vitamin and Mineral Supplement - Softgel (full strength)
Single full strength dose capsule taken one time
Experimental: ICAPS AREDS Softgel Capsule - Half Strength
ICAPS Eye Vitamin and Mineral Supplement - Softgel (half -strength)
Dietary supplement: ICAPS Eye Vitamin and Mineral Supplement - Softgel (half strength)
Single half strength dose capsule taken one time
Experimental: ICAPS AREDS coated tablets - Full Strength
ICAPS Eye Vitamin and Mineral Supplement - Coated Tablets
Dietary supplement: ICAPS Eye Vitamin and Mineral Supplement - Coated Tablets (full strength)
Single, full strength dose tablet taken one time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bioavailability of nutrients
Time Frame: 1 week for each treatment cross-over period
1 week for each treatment cross-over period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

January 27, 2010

First Submitted That Met QC Criteria

January 27, 2010

First Posted (Estimate)

January 28, 2010

Study Record Updates

Last Update Posted (Estimate)

February 2, 2012

Last Update Submitted That Met QC Criteria

January 31, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMA-09-32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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