Trial Outcomes & Findings for Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects (NCT NCT03750968)

Last Updated: 2023-07-11

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

47 participants

Primary outcome timeframe

up to 13 weeks gestation to birth

Results posted on

2023-07-11

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	24	23
Overall Study COMPLETED	21	20
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
Overall Study Adverse Event	2	0
Overall Study Lost to Follow-up	1	3

Baseline Characteristics

Participants who did not complete a final study visit were excluded from final data analysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Carotenoid Group n=21 Participants 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	Control Group n=20 Participants 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	Total n=41 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	30.8 years STANDARD_DEVIATION 3.1 • n=5 Participants	29.1 years STANDARD_DEVIATION 3.7 • n=7 Participants	29.9 years STANDARD_DEVIATION 1.2 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Maternal macular carotenoid levels	8809 unitless STANDARD_DEVIATION 3001 • n=5 Participants • Participants who did not complete a final study visit were excluded from final data analysis.	7002 unitless STANDARD_DEVIATION 2502 • n=7 Participants • Participants who did not complete a final study visit were excluded from final data analysis.	7906 unitless STANDARD_DEVIATION 2883 • n=5 Participants • Participants who did not complete a final study visit were excluded from final data analysis.
Maternal skin carotenoid levels	39981 Raman units STANDARD_DEVIATION 9495 • n=5 Participants	39436 Raman units STANDARD_DEVIATION 8733 • n=7 Participants	39709 Raman units STANDARD_DEVIATION 9021 • n=5 Participants
Maternal serum carotenoid levels	257.6 ng/ml STANDARD_DEVIATION 116.7 • n=5 Participants	217.0 ng/ml STANDARD_DEVIATION 82.5 • n=7 Participants	237.3 ng/ml STANDARD_DEVIATION 102.3 • n=5 Participants
Estimated dietary intake of lutein and zeaxanthin	4.3 mg/day STANDARD_DEVIATION 5.9 • n=5 Participants	3.6 mg/day STANDARD_DEVIATION 3.1 • n=7 Participants	4.0 mg/day STANDARD_DEVIATION 4.5 • n=5 Participants
Smoking habit Never smoked	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Smoking habit Smoked	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Alcohol intake frequency Never	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Alcohol intake frequency Occasional	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Body mass index (BMI)	23.9 kg/m^2 STANDARD_DEVIATION 3.7 • n=5 Participants	25.4 kg/m^2 STANDARD_DEVIATION 4.6 • n=7 Participants	24.7 kg/m^2 STANDARD_DEVIATION 4.1 • n=5 Participants

PRIMARY outcome

Timeframe: up to 13 weeks gestation to birth

Population: Participants who did not complete the final study visit were not included in the analysis.

Outcome measures

Outcome measures
Measure	Carotenoid Group n=21 Participants 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	Control Group n=20 Participants 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
Change in Maternal Macular Carotenoid Levels From Enrollment to Birth of Infant	12244 unitless Standard Error 688	7343 unitless Standard Error 470

PRIMARY outcome

Timeframe: up to 13 weeks gestation to birth

Population: Participants who did not complete the final study visit were not included in the analysis.

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

Outcome measures

Outcome measures
Measure	Carotenoid Group n=21 Participants 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	Control Group n=20 Participants 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
Change in Maternal Serum Carotenoid Levels From Enrollment to Birth of Infant	1030.2 Nanograms per milliliter Standard Error 86.8	252.0 Nanograms per milliliter Standard Error 33.4

PRIMARY outcome

Timeframe: up to 13 weeks gestation to birth

Population: Participants who did not complete a final study visit were excluded from final data analysis.

Maternal skin carotenoid levels are measured in Raman units.

Outcome measures

Outcome measures
Measure	Carotenoid Group n=21 Participants 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	Control Group n=20 Participants 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
Change in Maternal Skin Carotenoid Levels From Enrollment to Birth of Infant	55419 Raman units Standard Error 2421	38475 Raman units Standard Error 1932

SECONDARY outcome

Timeframe: Birth

Population: We report macular pigment optical density for infants whose mothers consented to ophthalmic imaging for their infant.

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

Outcome measures

Outcome measures
Measure	Carotenoid Group n=12 Participants 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	Control Group n=11 Participants 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
Infant Macular Carotenoid Levels as Determined by Macular Pigment Optical Density	0.05 unitless Standard Error 0.01	0.04 unitless Standard Error 0.01

SECONDARY outcome

Timeframe: Birth

Population: We report data on infants for whom we were able to obtain a blood sample.

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

Outcome measures

Outcome measures
Measure	Carotenoid Group n=19 Participants 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	Control Group n=18 Participants 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
Infant Serum Carotenoid Levels as Determined With High Performance Liquid Chromatography	270.5 nanograms per milliliter Standard Error 29.1	54.5 nanograms per milliliter Standard Error 6.6

SECONDARY outcome

Timeframe: Birth

Population: We report data on infants for whom we were able to obtain skin carotenoid measurements.

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

Outcome measures

Outcome measures
Measure	Carotenoid Group n=20 Participants 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	Control Group n=20 Participants 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
Infant Skin Carotenoid Levels as Determined With Resonance Raman Spectroscopy	31656 Raman units Standard Error 1279	23011 Raman units Standard Error 869

Adverse Events

Carotenoid Group

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Carotenoid Group n=24 participants at risk 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	Control Group n=23 participants at risk 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
Congenital, familial and genetic disorders Down syndrome	4.2% 1/24 • Number of events 1 • 8 months	0.00% 0/23 • 8 months
Congenital, familial and genetic disorders Multiple congenital abnormalities	4.2% 1/24 • Number of events 1 • 8 months	0.00% 0/23 • 8 months

Other adverse events

Other adverse events
Measure	Carotenoid Group n=24 participants at risk 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	Control Group n=23 participants at risk 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
Pregnancy, puerperium and perinatal conditions Gestational diabetes	4.2% 1/24 • Number of events 1 • 8 months	8.7% 2/23 • Number of events 2 • 8 months
Pregnancy, puerperium and perinatal conditions Gestational hypertension	4.2% 1/24 • Number of events 1 • 8 months	0.00% 0/23 • 8 months
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.00% 0/24 • 8 months	8.7% 2/23 • Number of events 2 • 8 months
Pregnancy, puerperium and perinatal conditions Anemia	0.00% 0/24 • 8 months	4.3% 1/23 • Number of events 1 • 8 months
Pregnancy, puerperium and perinatal conditions Exacerbated acne	4.2% 1/24 • Number of events 1 • 8 months	0.00% 0/23 • 8 months
Skin and subcutaneous tissue disorders Itching	4.2% 1/24 • Number of events 1 • 8 months	0.00% 0/23 • 8 months
Pregnancy, puerperium and perinatal conditions Torn placenta at delivery	0.00% 0/24 • 8 months	4.3% 1/23 • Number of events 1 • 8 months
Hepatobiliary disorders Cholestasis	0.00% 0/24 • 8 months	4.3% 1/23 • Number of events 1 • 8 months
Respiratory, thoracic and mediastinal disorders Sinus infection	4.2% 1/24 • Number of events 1 • 8 months	4.3% 1/23 • Number of events 1 • 8 months
Psychiatric disorders Worsening depression	4.2% 1/24 • Number of events 1 • 8 months	4.3% 1/23 • Number of events 1 • 8 months
Injury, poisoning and procedural complications Nose laceration	4.2% 1/24 • Number of events 1 • 8 months	0.00% 0/23 • 8 months
Infections and infestations COVID-19	8.3% 2/24 • Number of events 2 • 8 months	4.3% 1/23 • Number of events 1 • 8 months
Pregnancy, puerperium and perinatal conditions Preterm delivery	4.2% 1/24 • Number of events 1 • 8 months	0.00% 0/23 • 8 months

Additional Information

Paul Bernstein, MD, PhD

University of Utah John A. Moran Eye Center

Phone: 801-581-4069

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place