Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2026-01-04 @ 8:18 AM
Study NCT ID:
NCT03750968
Status:
COMPLETED
Last Update Posted:
2023-07-11
First Post:
2018-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D014975', 'term': 'Lutein'}, {'id': 'D065146', 'term': 'Zeaxanthins'}, {'id': 'D035061', 'term': 'Control Groups'}], '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'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Paul.Bernstein@hsc.utah.edu', 'phone': '801-581-4069', 'title': 'Paul Bernstein, MD, PhD', 'organization': 'University of Utah John A. Moran Eye Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'A limitation of this study was its lack of participant racial, ethnic and socioeconomic diversity. Also, by design, this first-in-humans, randomized clinical trial was limited to low-risk pregnancies. Due to funding and logistical limitations, we could not follow the mothers and their infants beyond their postpartum visit. This meant we were not able to assess the role of maternal breastmilk as a continued source of lutein an zeaxanthin during the first months of life.'}}, 'adverseEventsModule': {'timeFrame': '8 months', 'eventGroups': [{'id': 'EG000', 'title': 'Carotenoid Group', 'description': 'The Carotenoid group will receive a commercially available prenatal vitamin/mineral/DHA softgel plus a softgel containing lutein/zeaxanthin in safflower oil. Mother and infant are considered one unit enrolled in the Carotenoid group.\n\nCarotenoid Group: Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 6, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Control Group', 'description': 'The Control group will receive the same prenatal vitamin/mineral/DHA softgel plus a softgel containing only safflower oil. Mother and infant are considered one unit enrolled in the Control group.\n\nControl Group: Placebo ingredients: Safflower oil', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 8, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Gestational diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gestational hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pre-eclampsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Exacerbated acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Torn placenta at delivery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nose laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Preterm delivery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Down syndrome', 'notes': 'One infant in the carotenoid group was diagnosed with down syndrome at six weeks of age, which was confirmed by genetic testing. This adverse event originated before study enrollment and was therefore unrelated to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Multiple congenital abnormalities', 'notes': 'One infant in the carotenoid group was born prematurely with congenital abnormalities. This adverse event originated before study enrollment and was therefore unrelated to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Maternal Macular Carotenoid Levels From Enrollment to Birth of Infant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carotenoid Group', 'description': 'The Carotenoid group will receive a commercially available prenatal vitamin/mineral/DHA softgel plus a softgel containing lutein/zeaxanthin in safflower oil.\n\nCarotenoid Group: Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The Control group will receive the same prenatal vitamin/mineral/DHA softgel plus a softgel containing only safflower oil.\n\nControl Group: Placebo ingredients: Safflower oil'}], 'classes': [{'categories': [{'measurements': [{'value': '12244', 'spread': '688', 'groupId': 'OG000'}, {'value': '7343', 'spread': '470', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 13 weeks gestation to birth', 'description': 'measured in units of macular pigment optical volume (MPOV). Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2', 'unitOfMeasure': 'unitless', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who did not complete the final study visit were not included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Change in Maternal Serum Carotenoid Levels From Enrollment to Birth of Infant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carotenoid Group', 'description': 'The Carotenoid group will receive a commercially available prenatal vitamin/mineral/DHA softgel plus a softgel containing lutein/zeaxanthin in safflower oil.\n\nCarotenoid Group: Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The Control group will receive the same prenatal vitamin/mineral/DHA softgel plus a softgel containing only safflower oil.\n\nControl Group: Placebo ingredients: Safflower oil'}], 'classes': [{'categories': [{'measurements': [{'value': '1030.2', 'spread': '86.8', 'groupId': 'OG000'}, {'value': '252.0', 'spread': '33.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 13 weeks gestation to birth', 'description': 'We are reporting only lutein + zeaxanthin concentrations. Unit of measurement is in nanograms per milliliter (ng/ml). Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2', 'unitOfMeasure': 'Nanograms per milliliter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who did not complete the final study visit were not included in the analysis.'}, {'type': 'PRIMARY', 'title': 'Change in Maternal Skin Carotenoid Levels From Enrollment to Birth of Infant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carotenoid Group', 'description': 'The Carotenoid group will receive a commercially available prenatal vitamin/mineral/DHA softgel plus a softgel containing lutein/zeaxanthin in safflower oil.\n\nCarotenoid Group: Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The Control group will receive the same prenatal vitamin/mineral/DHA softgel plus a softgel containing only safflower oil.\n\nControl Group: Placebo ingredients: Safflower oil'}], 'classes': [{'categories': [{'measurements': [{'value': '55419', 'spread': '2421', 'groupId': 'OG000'}, {'value': '38475', 'spread': '1932', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 13 weeks gestation to birth', 'description': 'Maternal skin carotenoid levels are measured in Raman units.', 'unitOfMeasure': 'Raman units', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who did not complete a final study visit were excluded from final data analysis.'}, {'type': 'SECONDARY', 'title': 'Infant Macular Carotenoid Levels as Determined by Macular Pigment Optical Density', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carotenoid Group', 'description': 'The Carotenoid group will receive a commercially available prenatal vitamin/mineral/DHA softgel plus a softgel containing lutein/zeaxanthin in safflower oil.\n\nCarotenoid Group: Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The Control group will receive the same prenatal vitamin/mineral/DHA softgel plus a softgel containing only safflower oil.\n\nControl Group: Placebo ingredients: Safflower oil'}], 'classes': [{'categories': [{'measurements': [{'value': '0.05', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Birth', 'description': 'Comparison of macular carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids. Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2', 'unitOfMeasure': 'unitless', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'We report macular pigment optical density for infants whose mothers consented to ophthalmic imaging for their infant.'}, {'type': 'SECONDARY', 'title': 'Infant Serum Carotenoid Levels as Determined With High Performance Liquid Chromatography', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carotenoid Group', 'description': 'The Carotenoid group will receive a commercially available prenatal vitamin/mineral/DHA softgel plus a softgel containing lutein/zeaxanthin in safflower oil.\n\nCarotenoid Group: Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The Control group will receive the same prenatal vitamin/mineral/DHA softgel plus a softgel containing only safflower oil.\n\nControl Group: Placebo ingredients: Safflower oil'}], 'classes': [{'categories': [{'measurements': [{'value': '270.5', 'spread': '29.1', 'groupId': 'OG000'}, {'value': '54.5', 'spread': '6.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Birth', 'description': 'Comparison of carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids. We are reporting only lutein + zeaxanthin concentrations. Unit of measurement is nanogram per milliliter (ng/ml). Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2', 'unitOfMeasure': 'nanograms per milliliter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'We report data on infants for whom we were able to obtain a blood sample.'}, {'type': 'SECONDARY', 'title': 'Infant Skin Carotenoid Levels as Determined With Resonance Raman Spectroscopy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Carotenoid Group', 'description': 'The Carotenoid group will receive a commercially available prenatal vitamin/mineral/DHA softgel plus a softgel containing lutein/zeaxanthin in safflower oil.\n\nCarotenoid Group: Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The Control group will receive the same prenatal vitamin/mineral/DHA softgel plus a softgel containing only safflower oil.\n\nControl Group: Placebo ingredients: Safflower oil'}], 'classes': [{'categories': [{'measurements': [{'value': '31656', 'spread': '1279', 'groupId': 'OG000'}, {'value': '23011', 'spread': '869', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Birth', 'description': 'Comparison of carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids. Infant skin carotenoid levels are measured in Raman units. Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2', 'unitOfMeasure': 'Raman units', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'We report data on infants for whom we were able to obtain skin carotenoid measurements.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Carotenoid Group', 'description': 'The Carotenoid group will receive a commercially available prenatal vitamin/mineral/Docosahexaenoic acid (DHA) softgel plus a softgel containing lutein/zeaxanthin in safflower oil.\n\nCarotenoid Group: Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'The Control group will receive the same prenatal vitamin/mineral/Docosahexaenoic acid (DHA) softgel plus a softgel containing only safflower oil.\n\nControl Group: Placebo ingredients: Safflower oil'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'By definition, only mothers carrying one infant were included in the study. 24 mothers enrolled in the study were assigned to the carotenoid group and out of that, only 21 completed the study. The mother and infant were considered one unit. The 21 mothers and their infants were used for statistical analysis.', 'groupId': 'FG000', 'numSubjects': '24'}, {'comment': 'By definition, only mothers carrying one infant were included in the study. 23 mothers enrolled in the study were assigned to the control group and out of that, only 20 completed the study. The mother and infant were considered one unit. The 20 mothers and their infants were used for statistical analysis.', 'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'Only mothers were considered enrolled. One infant and one mother were considered one unit. The enrollment number and number of participants started/completed represents the number of dyads.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Carotenoid Group', 'description': 'The Carotenoid group will receive a commercially available prenatal vitamin/mineral/DHA softgel plus a softgel containing lutein/zeaxanthin in safflower oil.\n\nCarotenoid Group: Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'The Control group will receive the same prenatal vitamin/mineral/DHA softgel plus a softgel containing only safflower oil.\n\nControl Group: Placebo ingredients: Safflower oil'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.8', 'spread': '3.1', 'groupId': 'BG000'}, {'value': '29.1', 'spread': '3.7', 'groupId': 'BG001'}, {'value': '29.9', 'spread': '1.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Maternal macular carotenoid levels', 'classes': [{'categories': [{'measurements': [{'value': '8809', 'spread': '3001', 'groupId': 'BG000'}, {'value': '7002', 'spread': '2502', 'groupId': 'BG001'}, {'value': '7906', 'spread': '2883', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Macular pigment optical volume is a unitless measure. Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2', 'unitOfMeasure': 'unitless', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants who did not complete a final study visit were excluded from final data analysis.'}, {'title': 'Maternal skin carotenoid levels', 'classes': [{'categories': [{'measurements': [{'value': '39981', 'spread': '9495', 'groupId': 'BG000'}, {'value': '39436', 'spread': '8733', 'groupId': 'BG001'}, {'value': '39709', 'spread': '9021', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Skin carotenoid levels are measured in Raman units. Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2', 'unitOfMeasure': 'Raman units', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Maternal serum carotenoid levels', 'classes': [{'categories': [{'measurements': [{'value': '257.6', 'spread': '116.7', 'groupId': 'BG000'}, {'value': '217.0', 'spread': '82.5', 'groupId': 'BG001'}, {'value': '237.3', 'spread': '102.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'We are reporting only lutein + zeaxanthin concentrations. Unit of measurement is nanogram per milliliter (ng/ml).', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Estimated dietary intake of lutein and zeaxanthin', 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '5.9', 'groupId': 'BG000'}, {'value': '3.6', 'spread': '3.1', 'groupId': 'BG001'}, {'value': '4.0', 'spread': '4.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Estimated dietary intake of lutein and zeaxanthin combined is measured in milligrams per day (mg/day). At each study visit, mothers completed the lutein zeaxanthin questionnaire (LZQ™) quantitative food frequency questionnaire that captures \\~ 90% of the lutein/zeaxanthin foods consumed in the USA, based on the National Health and Nutrition Examination Survey (NHANES) data.', 'unitOfMeasure': 'mg/day', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking habit', 'classes': [{'categories': [{'title': 'Never smoked', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Smoked', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Smoking habit is measured on a per participant basis.', 'unitOfMeasure': 'Participants'}, {'title': 'Alcohol intake frequency', 'classes': [{'categories': [{'title': 'Never', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Occasional', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Alcohol intake frequency is measured on per participant basis.', 'unitOfMeasure': 'Participants'}, {'title': 'Body mass index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '23.9', 'spread': '3.7', 'groupId': 'BG000'}, {'value': '25.4', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '24.7', 'spread': '4.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Unit of measurement is kilogram per meter squared (kg/m\\^2).', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Baseline data were derived from the mothers. Participants who did not complete the final study visit were not included in the analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-21', 'size': 1904394, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-02T16:37', 'hasProtocol': True}, {'date': '2022-01-12', 'size': 281171, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-05-03T15:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-17', 'studyFirstSubmitDate': '2018-11-16', 'resultsFirstSubmitDate': '2023-05-03', 'studyFirstSubmitQcDate': '2018-11-20', 'lastUpdatePostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-17', 'studyFirstPostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Maternal Macular Carotenoid Levels From Enrollment to Birth of Infant', 'timeFrame': 'up to 13 weeks gestation to birth', 'description': 'measured in units of macular pigment optical volume (MPOV). Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2'}, {'measure': 'Change in Maternal Serum Carotenoid Levels From Enrollment to Birth of Infant', 'timeFrame': 'up to 13 weeks gestation to birth', 'description': 'We are reporting only lutein + zeaxanthin concentrations. Unit of measurement is in nanograms per milliliter (ng/ml). Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2'}, {'measure': 'Change in Maternal Skin Carotenoid Levels From Enrollment to Birth of Infant', 'timeFrame': 'up to 13 weeks gestation to birth', 'description': 'Maternal skin carotenoid levels are measured in Raman units.'}], 'secondaryOutcomes': [{'measure': 'Infant Macular Carotenoid Levels as Determined by Macular Pigment Optical Density', 'timeFrame': 'Birth', 'description': 'Comparison of macular carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids. Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2'}, {'measure': 'Infant Serum Carotenoid Levels as Determined With High Performance Liquid Chromatography', 'timeFrame': 'Birth', 'description': 'Comparison of carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids. We are reporting only lutein + zeaxanthin concentrations. Unit of measurement is nanogram per milliliter (ng/ml). Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2'}, {'measure': 'Infant Skin Carotenoid Levels as Determined With Resonance Raman Spectroscopy', 'timeFrame': 'Birth', 'description': 'Comparison of carotenoid levels of infants whose mothers received prenatal supplements without carotenoids to those mothers who received prenatal supplements with carotenoids. Infant skin carotenoid levels are measured in Raman units. Details regarding methods and criteria used to assess this outcome measure and interpret the values are in the published protocol available at https://doi.org/10.1186/s13063-021-05244-2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nutrient Deficiency', 'Pregnancy Related']}, 'referencesModule': {'references': [{'pmid': '37247819', 'type': 'DERIVED', 'citation': 'Addo EK, Allman SJ, Arunkumar R, Gorka JE, Harrison DY, Varner MW, Bernstein PS. Systemic Effects of Prenatal Carotenoid Supplementation in the Mother and her Child: The Lutein and Zeaxanthin in Pregnancy (L-ZIP) Randomized Trial -Report Number 1. J Nutr. 2023 Aug;153(8):2205-2215. doi: 10.1016/j.tjnut.2023.05.024. Epub 2023 May 27.'}, {'pmid': '33888136', 'type': 'DERIVED', 'citation': 'Addo EK, Gorusupudi A, Allman S, Bernstein PS. The Lutein and Zeaxanthin in Pregnancy (L-ZIP) study-carotenoid supplementation during pregnancy: ocular and systemic effects-study protocol for a randomized controlled trial. Trials. 2021 Apr 22;22(1):300. doi: 10.1186/s13063-021-05244-2.'}]}, 'descriptionModule': {'briefSummary': "This study is designed to test the hypotheses that (1) the third trimester of pregnancy is a period of maternal systemic and ocular carotenoid depletion; (2) prenatal supplementation with 10 milligrams of lutein and 2 milligrams of zeaxanthin will have significant effects on ocular and systemic biomarkers of maternal and infant carotenoid status relative to a matched, standard-of-care prenatal supplement without added lutein and zeaxanthin; and (3) newborn infants with the highest systemic and ocular carotenoid status will have more mature foveal structure.\n\nMothers will be enrolled in the study during their first trimester, and will take the study carotenoid or control supplements for 6 to 8 months. The final study outcome measurements of mothers and infants will be completed within two weeks of the baby's birth."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women, 18 or older of all races and ethnicities who have an uncomplicated obstetric history and plan to deliver either vaginally or by Caesarian section at the University of Utah for their current pregnancy.\n\nExclusion Criteria:\n\n* Women who have regularly taken carotenoid supplements containing more than 0.5 mg of lutein and/or zeaxanthin daily during the six months prior to screening\n* Women who have significant eye disease associated with macular pigment abnormalities such as Stargardt disease, albinism, or macular telangiectasia type II (MacTel).\n* Women with conditions associated with high-risk pregnancy such as adolescent pregnancy, multifetal pregnancy, current or past history of diabetes, pre-eclampsia, previous premature delivery, drug abuse or other significant medical illness'}, 'identificationModule': {'nctId': 'NCT03750968', 'acronym': 'L-ZIP', 'briefTitle': 'Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects', 'orgStudyIdInfo': {'id': 'IRB # 116610'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carotenoid group', 'description': 'The Carotenoid group will receive a commercially available prenatal vitamin/mineral/Docosahexaenoic acid (DHA) softgel plus a softgel containing lutein/zeaxanthin in safflower oil.', 'interventionNames': ['Drug: Carotenoid Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'The Control group will receive the same prenatal vitamin/mineral/Docosahexaenoic acid (DHA) softgel plus a softgel containing only safflower oil.', 'interventionNames': ['Dietary Supplement: Control Group']}], 'interventions': [{'name': 'Carotenoid Group', 'type': 'DRUG', 'otherNames': ['Softgel with lutein and zeaxanthin'], 'description': 'Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil', 'armGroupLabels': ['Carotenoid group']}, {'name': 'Control Group', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Softgel without lutein and zeaxanthin'], 'description': 'Placebo ingredients: Safflower oil', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah John A. Moran Eye Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Paul S Bernstein, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah Moran Eye Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paul S. Bernstein', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, Ophthalmology/Visual Sciences', 'investigatorFullName': 'Paul S. Bernstein', 'investigatorAffiliation': 'University of Utah'}}}}