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Completed

NCT Number: NCT03750968

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

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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Key information

Conditions

Nutrient Deficiency Pregnancy Related

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

University of Utah John A. Moran Eye Center

Salt Lake City, Utah, 84132, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carotenoid Group

Drug

Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil

Other names: Softgel with lutein and zeaxanthin

Control group

Dietary Supplement

Placebo ingredients: Safflower oil

Other names: Softgel without lutein and zeaxanthin

Primary outcomes

  1. Change in Maternal Macular Carotenoid Levels From Enrollment to Birth of Infant

    Time frame: up to 13 weeks gestation to birth

    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

  2. Change in Maternal Serum Carotenoid Levels From Enrollment to Birth of Infant

    Time frame: up to 13 weeks gestation to birth

    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

  3. Change in Maternal Skin Carotenoid Levels From Enrollment to Birth of Infant

    Time frame: up to 13 weeks gestation to birth

    Maternal skin carotenoid levels are measured in Raman units.

Secondary outcomes

  1. Infant Macular Carotenoid Levels as Determined by Macular Pigment Optical Density

    Time frame: Birth

    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

  2. Infant Serum Carotenoid Levels as Determined With High Performance Liquid Chromatography

    Time frame: Birth

    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

  3. Infant Skin Carotenoid Levels as Determined With Resonance Raman Spectroscopy

    Time frame: Birth

    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

Sponsors and collaborators

Lead sponsor

Paul S. Bernstein

Other

Registry information

Acronym: L-ZIP

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 23, 2018
Registry last updated
Jul 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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