Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-03-12 @ 10:43 AM
Study NCT ID:
NCT01528605
Status:
COMPLETED
Last Update Posted:
2014-08-29
First Post:
2011-12-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Lutein and Zeaxanthin Supplementation on Early Age-related Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}, {'id': 'D065146', 'term': 'Zeaxanthins'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'linbjmu@bjmu.edu.cn', 'phone': '010-82805336', 'title': 'Xiaoming Lin', 'organization': 'Peking University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 years, and ask for notable adverse effects for an average interval of 1 month.', 'description': '4 participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer. Subjects were encouraged to report any adverse effects immediately, and were asked specifically about adverse events such as carotenoderma every month during visits.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'starch in hard shell gelatine capsules\n\nplacebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks', 'otherNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low Lutein', 'description': 'low lutein group\n\nlow lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks', 'otherNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'High Lutein', 'description': 'high lutein group\n\nhigh lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks', 'otherNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Low Lutein Zeaxanthin', 'description': 'lutein plus zeaxanthin group\n\nlutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks', 'otherNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'High Zeaxanthin', 'description': 'zeaxanthin group\n\nhigh zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks', 'otherNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'High Lutein Zeaxanthin', 'description': 'Zeaxanthin plus lutein group\n\nzeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks', 'otherNumAtRisk': 28, 'otherNumAffected': 0, 'seriousNumAtRisk': 28, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes of Macular Pigment Optical Density (MPOD) During 48 Weeks and 2 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'starch in hard shell gelatine capsules\n\nplacebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks'}, {'id': 'OG001', 'title': 'Low Lutein', 'description': 'low lutein group\n\nlow lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks'}, {'id': 'OG002', 'title': 'High Lutein', 'description': 'high lutein group\n\nhigh lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks'}, {'id': 'OG003', 'title': 'Low Lutein Zeaxanthin', 'description': 'lutein plus zeaxanthin group\n\nlutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks'}, {'id': 'OG004', 'title': 'High Zeaxanthin', 'description': 'zeaxanthin group\n\nhigh zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks'}, {'id': 'OG005', 'title': 'High Lutein Zeaxanthin', 'description': 'Zeaxanthin plus lutein group\n\nzeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '0.315', 'spread': '0.144', 'groupId': 'OG000'}, {'value': '0.307', 'spread': '0.142', 'groupId': 'OG001'}, {'value': '0.315', 'spread': '0.122', 'groupId': 'OG002'}, {'value': '0.320', 'spread': '0.118', 'groupId': 'OG003'}, {'value': '0.327', 'spread': '0.117', 'groupId': 'OG004'}, {'value': '0.300', 'spread': '0.168', 'groupId': 'OG005'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '0.310', 'spread': '0.102', 'groupId': 'OG000'}, {'value': '0.353', 'spread': '0.125', 'groupId': 'OG001'}, {'value': '0.395', 'spread': '0.120', 'groupId': 'OG002'}, {'value': '0.356', 'spread': '0.150', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'High zeaxanthin Arm was added after the first 48 weeks to give additional information on the effect of zeaxanthin on MPOD and visual functions, therefore, the change of MPOD from baseline to 48 weeks is all we needed for this purpose.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': '"High Lutein Zeaxanthin" Arm was added after the first 48 weeks to give additional information on the effect of zeaxanthin on MPOD and visual functions, therefore, the change of MPOD from baseline to 48 weeks is all we needed for this purpose.', 'groupId': 'OG005'}]}]}, {'title': '48 weeks', 'categories': [{'measurements': [{'value': '0.316', 'spread': '0.110', 'groupId': 'OG000'}, {'value': '0.371', 'spread': '0.188', 'groupId': 'OG001'}, {'value': '0.424', 'spread': '0.142', 'groupId': 'OG002'}, {'value': '0.384', 'spread': '0.125', 'groupId': 'OG003'}, {'value': '0.384', 'spread': '0.139', 'groupId': 'OG004'}, {'value': '0.383', 'spread': '0.179', 'groupId': 'OG005'}]}]}, {'title': '2 years', 'categories': [{'measurements': [{'value': '0.324', 'spread': '0.163', 'groupId': 'OG000'}, {'value': '0.442', 'spread': '0.127', 'groupId': 'OG001'}, {'value': '0.441', 'spread': '0.133', 'groupId': 'OG002'}, {'value': '0.383', 'spread': '0.149', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'High zeaxanthin Arm was added after the first 48 weeks to give additional information on the effect of zeaxanthin on MPOD and visual functions, therefore, the change of MPOD from baseline to 48 weeks is all we needed for this purpose.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': '"High Lutein Zeaxanthin" Arm was added after the first 48 weeks to give additional information on the effect of zeaxanthin on MPOD and visual functions, therefore, the change of MPOD from baseline to 48 weeks is all we needed for this purpose.', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'The null hypothesis was no group difference', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'at baseline and 24 weeks, 48 weeks, 2 years during the intervention', 'description': "Macular pigment is found in the center of the retina known as the macula and is made up of the carotenoids lutein and zeaxanthin. This pigment serves to protect the macula from harmful blue light. The MPOD ranges from 0 to 1, with higher scores corresponding with greater density (protection). The autofluorescence picture of subject's macular was analyzed for MPOD values.\n\n4 participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer.", 'unitOfMeasure': 'density units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes of Serum Xanthophylls Concentrations During the Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'starch in hard shell gelatine capsules\n\nplacebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks'}, {'id': 'OG001', 'title': 'Low Lutein', 'description': 'low lutein group\n\nlow lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks'}, {'id': 'OG002', 'title': 'High Lutein', 'description': 'high lutein group\n\nhigh lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks'}, {'id': 'OG003', 'title': 'Low Lutein Zeaxanthin', 'description': 'lutein plus zeaxanthin group\n\nlutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '0.330', 'spread': '0.404', 'groupId': 'OG000'}, {'value': '0.318', 'spread': '0.251', 'groupId': 'OG001'}, {'value': '0.301', 'spread': '0.225', 'groupId': 'OG002'}, {'value': '0.244', 'spread': '0.263', 'groupId': 'OG003'}]}]}, {'title': '4 weeks', 'categories': [{'measurements': [{'value': '0.258', 'spread': '0.206', 'groupId': 'OG000'}, {'value': '0.870', 'spread': '0.573', 'groupId': 'OG001'}, {'value': '1.041', 'spread': '0.661', 'groupId': 'OG002'}, {'value': '0.965', 'spread': '0.711', 'groupId': 'OG003'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '0.355', 'spread': '0.356', 'groupId': 'OG000'}, {'value': '1.058', 'spread': '0.571', 'groupId': 'OG001'}, {'value': '1.450', 'spread': '0.930', 'groupId': 'OG002'}, {'value': '1.121', 'spread': '0.800', 'groupId': 'OG003'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '0.281', 'spread': '0.261', 'groupId': 'OG000'}, {'value': '0.973', 'spread': '0.618', 'groupId': 'OG001'}, {'value': '1.450', 'spread': '0.856', 'groupId': 'OG002'}, {'value': '1.109', 'spread': '0.567', 'groupId': 'OG003'}]}]}, {'title': '48 weeks', 'categories': [{'measurements': [{'value': '0.403', 'spread': '0.225', 'groupId': 'OG000'}, {'value': '1.350', 'spread': '0.503', 'groupId': 'OG001'}, {'value': '1.876', 'spread': '0.907', 'groupId': 'OG002'}, {'value': '1.136', 'spread': '0.542', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'The null hypothesis was no group difference', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'at baseline and 4, 12, 24 and 48 weeks during the intervention', 'description': 'Changes of serum xanthophylls concentrations measured by high performance liquid chromatograph (HPLC)at baseline and 4, 12, 24 and 48 weeks during the first 48 weeks of intervention.Four participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer.', 'unitOfMeasure': 'μmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes of Best-spectacle Corrected Visual Acuity (BSCVA) During the Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'starch in hard shell gelatine capsules\n\nplacebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks'}, {'id': 'OG001', 'title': 'Low Lutein', 'description': 'low lutein group\n\nlow lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks'}, {'id': 'OG002', 'title': 'High Lutein', 'description': 'high lutein group\n\nhigh lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks'}, {'id': 'OG003', 'title': 'Low Lutein Zeaxanthin', 'description': 'lutein plus zeaxanthin group\n\nlutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks'}, {'id': 'OG004', 'title': 'High Zeaxanthin', 'description': 'zeaxanthin group\n\nhigh zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks'}, {'id': 'OG005', 'title': 'High Lutein Zeaxanthin', 'description': 'Zeaxanthin plus lutein group\n\nzeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '53.037', 'spread': '9.338', 'groupId': 'OG000'}, {'value': '54.769', 'spread': '10.285', 'groupId': 'OG001'}, {'value': '54.539', 'spread': '8.056', 'groupId': 'OG002'}, {'value': '56.840', 'spread': '6.440', 'groupId': 'OG003'}, {'value': '56.481', 'spread': '7.073', 'groupId': 'OG004'}, {'value': '55.038', 'spread': '7.977', 'groupId': 'OG005'}]}]}, {'title': '24 weeks', 'categories': [{'measurements': [{'value': '53.444', 'spread': '12.509', 'groupId': 'OG000'}, {'value': '54.042', 'spread': '10.519', 'groupId': 'OG001'}, {'value': '56.444', 'spread': '8.617', 'groupId': 'OG002'}, {'value': '56.160', 'spread': '14.907', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'High zeaxanthin Arm was added after the first 48 weeks to give additional information on the effect of zeaxanthin on MPOD and visual functions, therefore, the change of BSCVA from baseline to 48 weeks is all we needed for this purpose.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': '"High Lutein Zeaxanthin" Arm was added after the first 48 weeks to give additional information on the effect of zeaxanthin on MPOD and visual functions, therefore, the change of BSCVA from baseline to 48 weeks is all we needed for this purpose.', 'groupId': 'OG005'}]}]}, {'title': '48 weeks', 'categories': [{'measurements': [{'value': '53.148', 'spread': '10.741', 'groupId': 'OG000'}, {'value': '56.250', 'spread': '10.920', 'groupId': 'OG001'}, {'value': '56.846', 'spread': '10.035', 'groupId': 'OG002'}, {'value': '60.875', 'spread': '4.919', 'groupId': 'OG003'}, {'value': '61.600', 'spread': '8.093', 'groupId': 'OG004'}, {'value': '58.500', 'spread': '9.437', 'groupId': 'OG005'}]}]}, {'title': '2 years', 'categories': [{'measurements': [{'value': '55.115', 'spread': '12.385', 'groupId': 'OG000'}, {'value': '56.840', 'spread': '7.587', 'groupId': 'OG001'}, {'value': '56.074', 'spread': '7.770', 'groupId': 'OG002'}, {'value': '56.600', 'spread': '11.839', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'High zeaxanthin Arm was added after the first 48 weeks to give additional information on the effect of zeaxanthin on MPOD and visual functions, therefore, the change of BSCVA from baseline to 48 weeks is all we needed for this purpose.', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': '"High Lutein Zeaxanthin" Arm was added after the first 48 weeks to give additional information on the effect of zeaxanthin on MPOD and visual functions, therefore, the change of BSCVA from baseline to 48 weeks is all we needed for this purpose.', 'groupId': 'OG005'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'groupDescription': 'The null hypothesis is "no group difference"', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'at baseline and 24 weeks, 48 weeks, 2 years during the intervention', 'description': 'best-spectacle corrected visual acuity (BSCVA) measured by ETDRS chart at baseline and 24 weeks, 48 weeks, 2 years during the intervention. Four participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer.', 'unitOfMeasure': 'letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes of Contrast Sensitivity (CSF) Measured by CSV-100 During the Intervention', 'timeFrame': 'at baseline, 24, 48 weeks and 2 years during the intervention', 'reportingStatus': 'NOT_POSTED', 'anticipatedPostingDate': '2015-12'}, {'type': 'SECONDARY', 'title': 'Changes of Flash Recovery Time (FRT) Measured by MDD-2 Macular Adaptometer', 'timeFrame': 'at baseline, 24, 48 weeks and 2 years during the intervention', 'description': 'Flash recovery time (FRT) was measured by MDD-2 macular adaptometer at baseline, 24, 48 and 96 weeks', 'reportingStatus': 'NOT_POSTED', 'anticipatedPostingDate': '2015-12'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Multifocal Electroretinogram (mfERG) at 48 Weeks', 'timeFrame': 'at baseline and 48 weeks during the intervention', 'reportingStatus': 'NOT_POSTED', 'anticipatedPostingDate': '2015-12'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in Microperimetry (MP) During the Intervention', 'timeFrame': 'at baseline, 24, 48 weeks and 2 years during the intervention', 'description': 'Microperimetry (MP) was measured by the MP1 Microperimeter', 'reportingStatus': 'NOT_POSTED', 'anticipatedPostingDate': '2015-12'}, {'type': 'SECONDARY', 'title': 'Changes of Food Pattern From Baseline by Food Frequency Questionnaire During the Intervention', 'timeFrame': 'at baseline, 24, 48 weeks and 2 years', 'reportingStatus': 'NOT_POSTED', 'anticipatedPostingDate': '2015-12'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Lutein', 'description': 'low lutein group\n\nlow lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'starch in hard shell gelatine capsules\n\nplacebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks'}, {'id': 'FG002', 'title': 'High Lutein', 'description': 'high lutein group\n\nhigh lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks'}, {'id': 'FG003', 'title': 'Low Lutein Zeaxanthin', 'description': 'lutein plus zeaxanthin group\n\nlutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks'}, {'id': 'FG004', 'title': 'High Zeaxanthin', 'description': 'zeaxanthin group\n\nhigh zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks'}, {'id': 'FG005', 'title': 'High Lutein Zeaxanthin', 'description': 'Zeaxanthin plus lutein group\n\nzeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '28'}, {'groupId': 'FG003', 'numSubjects': '28'}, {'groupId': 'FG004', 'numSubjects': '28'}, {'groupId': 'FG005', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '27'}, {'groupId': 'FG004', 'numSubjects': '28'}, {'groupId': 'FG005', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'We added "High Zeaxanthin" and "High Lutein Zeaxanthin" Arms at the seconde year for additional information on the effect of zeaxanthin on MPOD and visual functions. Therefore, we did not measure the changes of serum concentration, and only measured the change of MOPD and visual functions at baseline and 48 weeks, in the two new groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}, {'value': '164', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Lutein', 'description': 'low lutein group\n\nlow lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'starch in hard shell gelatine capsules\n\nplacebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks'}, {'id': 'BG002', 'title': 'High Lutein', 'description': 'high lutein group\n\nhigh lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks'}, {'id': 'BG003', 'title': 'Low Lutein Zeaxanthin', 'description': 'lutein plus zeaxanthin group\n\nlutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks'}, {'id': 'BG004', 'title': 'High Zeaxanthin', 'description': 'zeaxanthin group\n\nhigh zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks'}, {'id': 'BG005', 'title': 'High Lutein Zeaxanthin', 'description': 'Zeaxanthin plus lutein group\n\nzeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.7', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '69.0', 'spread': '7.5', 'groupId': 'BG001'}, {'value': '69.3', 'spread': '6.9', 'groupId': 'BG002'}, {'value': '68.5', 'spread': '6.9', 'groupId': 'BG003'}, {'value': '69.7', 'spread': '5.4', 'groupId': 'BG004'}, {'value': '69.1', 'spread': '8.1', 'groupId': 'BG005'}, {'value': '69.2', 'spread': '7.6', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '94', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '70', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}, {'value': '164', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '4 participants was excluded during the analysis since they did not finish the intervention.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-18', 'studyFirstSubmitDate': '2011-12-28', 'resultsFirstSubmitDate': '2014-07-20', 'studyFirstSubmitQcDate': '2012-02-04', 'lastUpdatePostDateStruct': {'date': '2014-08-29', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-08-18', 'studyFirstPostDateStruct': {'date': '2012-02-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of Macular Pigment Optical Density (MPOD) During 48 Weeks and 2 Years', 'timeFrame': 'at baseline and 24 weeks, 48 weeks, 2 years during the intervention', 'description': "Macular pigment is found in the center of the retina known as the macula and is made up of the carotenoids lutein and zeaxanthin. This pigment serves to protect the macula from harmful blue light. The MPOD ranges from 0 to 1, with higher scores corresponding with greater density (protection). The autofluorescence picture of subject's macular was analyzed for MPOD values.\n\n4 participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer."}], 'secondaryOutcomes': [{'measure': 'Changes of Serum Xanthophylls Concentrations During the Intervention', 'timeFrame': 'at baseline and 4, 12, 24 and 48 weeks during the intervention', 'description': 'Changes of serum xanthophylls concentrations measured by high performance liquid chromatograph (HPLC)at baseline and 4, 12, 24 and 48 weeks during the first 48 weeks of intervention.Four participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer.'}, {'measure': 'Changes of Best-spectacle Corrected Visual Acuity (BSCVA) During the Intervention', 'timeFrame': 'at baseline and 24 weeks, 48 weeks, 2 years during the intervention', 'description': 'best-spectacle corrected visual acuity (BSCVA) measured by ETDRS chart at baseline and 24 weeks, 48 weeks, 2 years during the intervention. Four participants was excluded during the analysis since they did not finish the intervention. Three did not finish the follow up, while one died from breast cancer.'}, {'measure': 'Changes of Contrast Sensitivity (CSF) Measured by CSV-100 During the Intervention', 'timeFrame': 'at baseline, 24, 48 weeks and 2 years during the intervention'}, {'measure': 'Changes of Flash Recovery Time (FRT) Measured by MDD-2 Macular Adaptometer', 'timeFrame': 'at baseline, 24, 48 weeks and 2 years during the intervention', 'description': 'Flash recovery time (FRT) was measured by MDD-2 macular adaptometer at baseline, 24, 48 and 96 weeks'}, {'measure': 'Changes From Baseline in Multifocal Electroretinogram (mfERG) at 48 Weeks', 'timeFrame': 'at baseline and 48 weeks during the intervention'}, {'measure': 'Changes From Baseline in Microperimetry (MP) During the Intervention', 'timeFrame': 'at baseline, 24, 48 weeks and 2 years during the intervention', 'description': 'Microperimetry (MP) was measured by the MP1 Microperimeter'}, {'measure': 'Changes of Food Pattern From Baseline by Food Frequency Questionnaire During the Intervention', 'timeFrame': 'at baseline, 24, 48 weeks and 2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['lutein', 'zeaxanthin', 'age-related macular degeneration', 'supplementation', 'macular pigment optical density', 'visual function', 'serum concentration'], 'conditions': ['Age-related Macular Degeneration']}, 'referencesModule': {'references': [{'pmid': '22835510', 'type': 'DERIVED', 'citation': 'Ma L, Dou HL, Huang YM, Lu XR, Xu XR, Qian F, Zou ZY, Pang HL, Dong PC, Xiao X, Wang X, Sun TT, Lin XM. Improvement of retinal function in early age-related macular degeneration after lutein and zeaxanthin supplementation: a randomized, double-masked, placebo-controlled trial. Am J Ophthalmol. 2012 Oct;154(4):625-634.e1. doi: 10.1016/j.ajo.2012.04.014. Epub 2012 Jul 25.'}]}, 'descriptionModule': {'briefSummary': 'This study is to investigate the protective effects of supplemental lutein and zeaxanthin on early age-related macular degeneration (AMD) patients in China.', 'detailedDescription': 'Early age-related macular degeneration (AMD) is an early hallmark of irreversible vision impairment accompanying with senescence of macular. Given the fact in treatment, prevention strategy is thought to be an efficient and robust approach to diminish early AMD patients in low-income countries, however, feasible cocktail provision in most developing nations remain mysteries. Here we proposed an effective cocktail treatment with different amounts of lutein and zeaxanthin could increase the macular pigment optical density (MPOD) and serum xanthophylls concentrations among randomized Chinese AMD patients; and might improve visual function measured by visual performance indices such as best-spectacle corrected visual acuity (BSCVA), contrast sensitivity (CSF), flash recovery time (FRT), multifocal electroretinogram (mfERG) and microperimetry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* aged over 50 years, Chinese of the Han nationality\n* diagnosed as age-related macular degeneration\n* did not take lutein or zeaxanthin supplements in the past half a year\n* good general health\n* corrected visual acuity above 0.25 (20/80)\n* did not take optical laser or medical treatments\n\nExclusion Criteria:\n\n* had other ocular diseases, such as glaucoma, macular pucker, optic neuropathy, diabetic retinopathy etc.\n* had nervous system diseases, stroke, Type I diabetes\n* had diseases effected nutrients absorption, such as Crohn' s disease\n* had turbid ocular media or transplanted intraocular lenses\n* reported abnormal digestive condition"}, 'identificationModule': {'nctId': 'NCT01528605', 'briefTitle': 'Effects of Lutein and Zeaxanthin Supplementation on Early Age-related Macular Degeneration', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'The Effects of Lutein and Zeaxanthin Supplementations on Early Age-related Macular Degeneration', 'orgStudyIdInfo': {'id': 'NNSFC-30872113'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'starch in hard shell gelatine capsules', 'interventionNames': ['Dietary Supplement: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Low lutein', 'description': 'low lutein group', 'interventionNames': ['Dietary Supplement: low lutein']}, {'type': 'EXPERIMENTAL', 'label': 'High lutein', 'description': 'high lutein group', 'interventionNames': ['Dietary Supplement: high lutein']}, {'type': 'EXPERIMENTAL', 'label': 'Low lutein zeaxanthin', 'description': 'lutein plus zeaxanthin group', 'interventionNames': ['Dietary Supplement: lutein plus zeaxanthin']}, {'type': 'EXPERIMENTAL', 'label': 'High zeaxanthin', 'description': 'zeaxanthin group', 'interventionNames': ['Dietary Supplement: high zeaxanthin']}, {'type': 'EXPERIMENTAL', 'label': 'high lutein zeaxanthin', 'description': 'Zeaxanthin plus lutein group', 'interventionNames': ['Dietary Supplement: zeaxanthin plus lutein']}], 'interventions': [{'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo, one gelatine capsule containing starch per day, for 96 weeks', 'armGroupLabels': ['Placebo']}, {'name': 'low lutein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'one gelatine capsule containing 10mg lutein per day, for 96 weeks', 'armGroupLabels': ['Low lutein']}, {'name': 'high lutein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'one gelatine capsule containing 20mg lutein per day, for 96 weeks', 'armGroupLabels': ['High lutein']}, {'name': 'lutein plus zeaxanthin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks', 'armGroupLabels': ['Low lutein zeaxanthin']}, {'name': 'high zeaxanthin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks', 'armGroupLabels': ['High zeaxanthin']}, {'name': 'zeaxanthin plus lutein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks', 'armGroupLabels': ['high lutein zeaxanthin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Haidian District', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Xiaoming Lin, M.M.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Principal Investigator', 'investigatorFullName': 'Xiaoming Lin', 'investigatorAffiliation': 'Peking University'}}}}