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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.
Mothers 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carotenoid group | Experimental | The Carotenoid group will receive a commercially available prenatal vitamin/mineral/Docosahexaenoic acid (DHA) softgel plus a softgel containing lutein/zeaxanthin in safflower oil. |
|
| Control group | Active Comparator | The Control group will receive the same prenatal vitamin/mineral/Docosahexaenoic acid (DHA) softgel plus a softgel containing only safflower oil. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carotenoid Group | Drug | Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Maternal Macular Carotenoid Levels From Enrollment to Birth of Infant | 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 | up to 13 weeks gestation to birth |
| Change in Maternal Serum Carotenoid Levels From Enrollment to Birth of Infant | 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 | up to 13 weeks gestation to birth |
| Change in Maternal Skin Carotenoid Levels From Enrollment to Birth of Infant | Maternal skin carotenoid levels are measured in Raman units. | up to 13 weeks gestation to birth |
| Measure | Description | Time Frame |
|---|---|---|
| Infant Macular Carotenoid Levels as Determined by Macular Pigment Optical Density | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul S Bernstein, MD, PhD | University of Utah Moran Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah John A. Moran Eye Center | Salt Lake City | Utah | 84132 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37247819 | Derived | 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. | |
| 33888136 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Carotenoid Group | The Carotenoid group will receive a commercially available prenatal vitamin/mineral/Docosahexaenoic acid (DHA) softgel plus a softgel containing lutein/zeaxanthin in safflower oil. Carotenoid Group: Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil |
| FG001 | Control Group | The Control group will receive the same prenatal vitamin/mineral/Docosahexaenoic acid (DHA) softgel plus a softgel containing only safflower oil. Control Group: Placebo ingredients: Safflower oil |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline data were derived from the mothers. Participants who did not complete the final study visit were not included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Carotenoid Group | The Carotenoid group will receive a commercially available prenatal vitamin/mineral/DHA softgel plus a softgel containing lutein/zeaxanthin in safflower oil. Carotenoid Group: Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Maternal Macular Carotenoid Levels From Enrollment to Birth of Infant | 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 | Participants who did not complete the final study visit were not included in the analysis. | Posted | Mean | Standard Error | unitless | up to 13 weeks gestation to birth |
|
8 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Carotenoid Group | 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. Carotenoid Group: Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Down syndrome | Congenital, familial and genetic disorders | Systematic Assessment | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gestational diabetes | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Bernstein, MD, PhD | University of Utah John A. Moran Eye Center | 801-581-4069 | Paul.Bernstein@hsc.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2022 | May 2, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 12, 2022 | May 3, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D014975 | Lutein |
| D065146 | Zeaxanthins |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D024341 | Xanthophylls |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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| Control Group | Dietary Supplement | Placebo ingredients: Safflower oil |
|
|
| Birth |
| Infant Serum Carotenoid Levels as Determined With High Performance Liquid Chromatography | 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 | Birth |
| Infant Skin Carotenoid Levels as Determined With Resonance Raman Spectroscopy | 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 | Birth |
| 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. |
The Control group will receive the same prenatal vitamin/mineral/DHA softgel plus a softgel containing only safflower oil. Control Group: Placebo ingredients: Safflower oil |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Maternal macular carotenoid levels | 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 | Participants who did not complete a final study visit were excluded from final data analysis. | Mean | Standard Deviation | unitless |
|
| Maternal skin carotenoid levels | 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 | Mean | Standard Deviation | Raman units |
|
| Maternal serum carotenoid levels | We are reporting only lutein + zeaxanthin concentrations. Unit of measurement is nanogram per milliliter (ng/ml). | Mean | Standard Deviation | ng/ml |
|
| Estimated dietary intake of lutein and zeaxanthin | 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. | Mean | Standard Deviation | mg/day |
|
| Smoking habit | Smoking habit is measured on a per participant basis. | Count of Participants | Participants |
|
| Alcohol intake frequency | Alcohol intake frequency is measured on per participant basis. | Count of Participants | Participants |
|
| Body mass index (BMI) | Unit of measurement is kilogram per meter squared (kg/m^2). | Mean | Standard Deviation | kg/m^2 |
|
| Control Group |
The Control group will receive the same prenatal vitamin/mineral/DHA softgel plus a softgel containing only safflower oil. Control Group: Placebo ingredients: Safflower oil |
|
|
| Primary | Change in Maternal Serum Carotenoid Levels From Enrollment to Birth of Infant | 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 | Participants who did not complete the final study visit were not included in the analysis. | Posted | Mean | Standard Error | Nanograms per milliliter | up to 13 weeks gestation to birth |
|
|
|
| Primary | Change in Maternal Skin Carotenoid Levels From Enrollment to Birth of Infant | Maternal skin carotenoid levels are measured in Raman units. | Participants who did not complete a final study visit were excluded from final data analysis. | Posted | Mean | Standard Error | Raman units | up to 13 weeks gestation to birth |
|
|
|
| Secondary | Infant Macular Carotenoid Levels as Determined by Macular Pigment Optical Density | 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 | We report macular pigment optical density for infants whose mothers consented to ophthalmic imaging for their infant. | Posted | Mean | Standard Error | unitless | Birth |
|
|
|
| Secondary | Infant Serum Carotenoid Levels as Determined With High Performance Liquid Chromatography | 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 | We report data on infants for whom we were able to obtain a blood sample. | Posted | Mean | Standard Error | nanograms per milliliter | Birth |
|
|
|
| Secondary | Infant Skin Carotenoid Levels as Determined With Resonance Raman Spectroscopy | 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 | We report data on infants for whom we were able to obtain skin carotenoid measurements. | Posted | Mean | Standard Error | Raman units | Birth |
|
|
|
| 0 |
| 24 |
| 2 |
| 24 |
| 6 |
| 24 |
| EG001 | Control Group | 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. Control Group: Placebo ingredients: Safflower oil | 0 | 23 | 0 | 23 | 8 | 23 |
|
| Multiple congenital abnormalities | Congenital, familial and genetic disorders | Systematic Assessment | 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. |
|
| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Anemia | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Exacerbated acne | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Torn placenta at delivery | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | Systematic Assessment |
|
| Sinus infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Worsening depression | Psychiatric disorders | Systematic Assessment |
|
| Nose laceration | Injury, poisoning and procedural complications | Systematic Assessment |
|
| COVID-19 | Infections and infestations | Systematic Assessment |
|
| Preterm delivery | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
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| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |