Bioavailability of Nutrients Contained in Softgel Capsules vs Tablets

Phase 4

Completed

• Conditions: Vision
• Interventions: 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)

• Registration Number: NCT01057966
• Lead Sponsor: Alcon Research

Brief Summary

This study is a comparison of the bioavailability of nutrients contained in softgel capsules vs tablets.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-01-27
• Study First Submitted QC: 2010-01-27
• Study First Posted: 2010-01-28
• Study Start: 2010-02
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-31
• Last Update Posted: 2012-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ICAPS AREDS Softgel Capsule - Full Strength	ICAPS Eye Vitamin and Mineral Supplement - Softgel (full strength)	ICAPS Eye Vitamin and Mineral Supplement - Softgel
ICAPS AREDS Softgel Capsule - Half Strength	ICAPS Eye Vitamin and Mineral Supplement - Softgel (half strength)	ICAPS Eye Vitamin and Mineral Supplement - Softgel (half -strength)
ICAPS AREDS coated tablets - Full Strength	ICAPS Eye Vitamin and Mineral Supplement - Coated Tablets (full strength)	ICAPS Eye Vitamin and Mineral Supplement - Coated Tablets

Primary Outcome Measures

Name	Time	Method
Bioavailability of nutrients	1 week for each treatment cross-over period

Trial Locations

Locations (1)

Contact Alcon Call Center For Trial Locations; 🇺🇸 Fort Worth, Texas, United States