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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
  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: Open Label
Primary Purpose: Supportive Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Bioavailability of nutrients [ Time Frame: 1 week for each treatment cross-over period ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01057966     History of Changes
Other Study ID Numbers: SMA-09-32
Study First Received: January 27, 2010
Last Updated: January 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Bioavailability
Ocular Vitamins

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

ClinicalTrials.gov processed this record on June 18, 2013