Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-01-02 @ 9:51 AM
Study NCT ID:
NCT01057966
Status:
COMPLETED
Last Update Posted:
2012-02-02
First Post:
2010-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability of Nutrients Contained in Softgel Capsules vs Tablets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-31', 'studyFirstSubmitDate': '2010-01-27', 'studyFirstSubmitQcDate': '2010-01-27', 'lastUpdatePostDateStruct': {'date': '2012-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioavailability of nutrients', 'timeFrame': '1 week for each treatment cross-over period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioavailability', 'Ocular Vitamins'], 'conditions': ['Vision']}, 'descriptionModule': {'briefSummary': 'This study is a comparison of the bioavailability of nutrients contained in softgel capsules vs tablets.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 to 35\n2. Body Mass Index (BMI) 21-27 kg/m2\n3. Must be able to give written informed consent\n4. Subjects must be willing to comply with all study requirements.\n5. Subjects must understand, sign and be given a copy of the written Informed Consent form.\n\nExclusion Criteria:\n\n1. Subjects for whom both eyes do not meet all inclusion criteria and either eye meets exclusion criteria\n2. Subjects who are pregnant, lactating or planning to be pregnant during the course of the study\n3. Subjects with known sensitivity to planned study concomitant medications\n4. Subjects participating in any other ophthalmic drug or device clinical trial within 30 days of this clinical investigation.\n5. Use of ocular drugs, other than study medications, during the study and within 14 days prior to study entry or any other ocular medication'}, 'identificationModule': {'nctId': 'NCT01057966', 'briefTitle': 'Bioavailability of Nutrients Contained in Softgel Capsules vs Tablets', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'SMA-09-32'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ICAPS AREDS Softgel Capsule - Full Strength', 'description': 'ICAPS Eye Vitamin and Mineral Supplement - Softgel', 'interventionNames': ['Dietary Supplement: ICAPS Eye Vitamin and Mineral Supplement - Softgel (full strength)']}, {'type': 'EXPERIMENTAL', 'label': 'ICAPS AREDS Softgel Capsule - Half Strength', 'description': 'ICAPS Eye Vitamin and Mineral Supplement - Softgel (half -strength)', 'interventionNames': ['Dietary Supplement: ICAPS Eye Vitamin and Mineral Supplement - Softgel (half strength)']}, {'type': 'EXPERIMENTAL', 'label': 'ICAPS AREDS coated tablets - Full Strength', 'description': 'ICAPS Eye Vitamin and Mineral Supplement - Coated Tablets', 'interventionNames': ['Dietary Supplement: ICAPS Eye Vitamin and Mineral Supplement - Coated Tablets (full strength)']}], 'interventions': [{'name': 'ICAPS Eye Vitamin and Mineral Supplement - Softgel (full strength)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Single full strength dose capsule taken one time', 'armGroupLabels': ['ICAPS AREDS Softgel Capsule - Full Strength']}, {'name': 'ICAPS Eye Vitamin and Mineral Supplement - Softgel (half strength)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Single half strength dose capsule taken one time', 'armGroupLabels': ['ICAPS AREDS Softgel Capsule - Half Strength']}, {'name': 'ICAPS Eye Vitamin and Mineral Supplement - Coated Tablets (full strength)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Single, full strength dose tablet taken one time', 'armGroupLabels': ['ICAPS AREDS coated tablets - Full Strength']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Contact Alcon Call Center For Trial Locations', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}