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Bioavailability of Nutrients Contained in Softgel Capsules vs Tablets

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ClinicalTrials.gov Identifier: NCT01057966
Recruitment Status : Completed
First Posted : January 28, 2010
Last Update Posted : February 2, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Tracking Information
First Submitted Date  ICMJE January 27, 2010
First Posted Date  ICMJE January 28, 2010
Last Update Posted Date February 2, 2012
Study Start Date  ICMJE February 2010
Actual 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 ]
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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 Arms  ICMJE
  • 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
Actual Enrollment  ICMJE
 (submitted: January 27, 2010)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01057966
Other Study ID Numbers  ICMJE SMA-09-32
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alcon Research
Study Sponsor  ICMJE Alcon Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Alcon Research
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP