Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 4:03 PM
Study NCT ID:
NCT01042860
Status:
COMPLETED
Last Update Posted:
2010-01-08
First Post:
2010-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Lutein Supplements on Age-related Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014975', 'term': 'Lutein'}], 'ancestors': [{'id': 'D024341', 'term': 'Xanthophylls'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-07', 'studyFirstSubmitDate': '2010-01-05', 'studyFirstSubmitQcDate': '2010-01-05', 'lastUpdatePostDateStruct': {'date': '2010-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Macular Pigment Optical Density', 'timeFrame': 'Baseline, 4 months, 8 months, 12 months'}], 'secondaryOutcomes': [{'measure': 'Visual Acuity', 'timeFrame': 'Baseline, 4 months, 8 months, 12 months'}]}, 'conditionsModule': {'keywords': ['macular pigment', 'lutein', 'age-related macular degeneration', 'AMD'], 'conditions': ['Age-Related Macular Degeneration']}, 'referencesModule': {'references': [{'pmid': '23385792', 'type': 'DERIVED', 'citation': 'Murray IJ, Makridaki M, van der Veen RL, Carden D, Parry NR, Berendschot TT. Lutein supplementation over a one-year period in early AMD might have a mild beneficial effect on visual acuity: the CLEAR study. Invest Ophthalmol Vis Sci. 2013 Mar 11;54(3):1781-8. doi: 10.1167/iovs.12-10715.'}]}, 'descriptionModule': {'briefSummary': 'Rationale: Age-related macular degeneration is the most common cause of blindness in the industrialized world. Macular pigment is hypothesized to protect against the vision loss in this disease.\n\nObjective: 1. To study if the macular pigment optical density can be raised by lutein supplementation. 2. To study if lutein supplementation can stop or slow down the decrease in visual functions.\n\nStudy design: Randomized, double blind, placebo controlled intervention study.\n\nStudy population: Eighty patients with early signs of age-related macular degeneration Intervention: The intervention group (40 subjects) receives 10 mg lutein per day, while the control group (40 subjects) gets a placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AMD grade 2 or 3\n* visual acuity \\> 0.5\n* BMI \\< 30\n\nExclusion Criteria:\n\n* using lutein supplements\n* smoking\n* diabetes\n* diseases that interfere with lipid absorption\n* other eye diseases'}, 'identificationModule': {'nctId': 'NCT01042860', 'briefTitle': 'The Influence of Lutein Supplements on Age-related Macular Degeneration', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'The Influence of Lutein Supplements on Age-related Macular Degeneration', 'orgStudyIdInfo': {'id': '061052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'supplement', 'description': 'lutein supplement', 'interventionNames': ['Dietary Supplement: Lutein']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Lutein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Lutein supplement, 10 mg daily', 'armGroupLabels': ['supplement']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6202 AZ', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'University Eye Clinic Maastricht', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': 'M60 1QD', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Faculty of Life Sciences, University of Manchester', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Tos TJM Berendschot, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Eye Clinic Maastricht'}, {'name': 'Ian J Murray, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manchester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cognis Deutschland GmbH & Co. KG', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Dr. Christine Gärtner', 'oldOrganization': 'Cognis Deutschland GmbH & Co. KG'}}}}