Bioavailability of Nutrients Contained in Softgel Capsules vs Tablets

NCT ID: NCT01057966

Last Updated: 2012-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-09-30

Brief Summary

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

Detailed Description

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Conditions

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Vision

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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ICAPS AREDS Softgel Capsule - Full Strength

ICAPS Eye Vitamin and Mineral Supplement - Softgel

Group Type EXPERIMENTAL

ICAPS Eye Vitamin and Mineral Supplement - Softgel (full strength)

Intervention Type DIETARY_SUPPLEMENT

Single full strength dose capsule taken one time

ICAPS AREDS Softgel Capsule - Half Strength

ICAPS Eye Vitamin and Mineral Supplement - Softgel (half -strength)

Group Type EXPERIMENTAL

ICAPS Eye Vitamin and Mineral Supplement - Softgel (half strength)

Intervention Type DIETARY_SUPPLEMENT

Single half strength dose capsule taken one time

ICAPS AREDS coated tablets - Full Strength

ICAPS Eye Vitamin and Mineral Supplement - Coated Tablets

Group Type EXPERIMENTAL

ICAPS Eye Vitamin and Mineral Supplement - Coated Tablets (full strength)

Intervention Type DIETARY_SUPPLEMENT

Single, full strength dose tablet taken one time

Interventions

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ICAPS Eye Vitamin and Mineral Supplement - Softgel (full strength)

Single full strength dose capsule taken one time

Intervention Type DIETARY_SUPPLEMENT

ICAPS Eye Vitamin and Mineral Supplement - Softgel (half strength)

Single half strength dose capsule taken one time

Intervention Type DIETARY_SUPPLEMENT

ICAPS Eye Vitamin and Mineral Supplement - Coated Tablets (full strength)

Single, full strength dose tablet taken one time

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Contact Alcon Call Center For Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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SMA-09-32

Identifier Type: -

Identifier Source: org_study_id

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