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Bioavailability of Nutrients Contained in Softgel Capsules vs Tablets

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01057966
First Posted: January 28, 2010
Last Update Posted: February 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
  Purpose
This study is a comparison of the bioavailability of nutrients contained in softgel capsules vs tablets.

Condition Intervention Phase
Vision Dietary Supplement: ICAPS Eye Vitamin and Mineral Supplement - Softgel (full strength) Dietary Supplement: ICAPS Eye Vitamin and Mineral Supplement - Softgel (half strength) Dietary Supplement: ICAPS Eye Vitamin and Mineral Supplement - Coated Tablets (full strength) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Bioavailability of nutrients [ Time Frame: 1 week for each treatment cross-over period ]

Enrollment: 15
Study Start Date: February 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01057966


Locations
United States, Texas
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01057966     History of Changes
Other Study ID Numbers: SMA-09-32
First Submitted: January 27, 2010
First Posted: January 28, 2010
Last Update Posted: February 2, 2012
Last Verified: January 2012

Keywords provided by Alcon Research:
Bioavailability
Ocular Vitamins

Additional relevant MeSH terms:
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs