Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects

Pregnancy Related Clinical Trial

— L-ZIP  

Official title:

Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03750968
• Other study ID #: IRB # 116610
• Status: Completed
• Phase: Phase 2
• Start date: September 26, 2019
• Est. completion date: January 31, 2022

Study information

• Verified date: June 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• Women who have significant eye disease associated with macular pigment abnormalities such as Stargardt disease, albinism, or macular telangiectasia type II (MacTel).
• 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

Related Conditions & MeSH terms

• Nutrient Deficiency
• Pregnancy Related

Intervention

Drug:
• Carotenoid Group
Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil

Dietary Supplement:
• Control Group
Placebo ingredients: Safflower oil

Locations

Country	Name	City	State
United States	University of Utah John A. Moran Eye Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Paul S. Bernstein

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	up to 13 weeks gestation to birth
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	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.	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	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	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	Birth