Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects (L-ZIP)

June 17, 2023 updated by: Paul S. Bernstein

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah John A. Moran Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil
Other Names:
  • Softgel with lutein and zeaxanthin
Active Comparator: Control group
The Control group will receive the same prenatal vitamin/mineral/Docosahexaenoic acid (DHA) softgel plus a softgel containing only safflower oil.
Placebo ingredients: Safflower oil
Other Names:
  • Softgel without lutein and zeaxanthin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 13 weeks gestation to birth
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
up to 13 weeks gestation to birth
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.
up to 13 weeks gestation to birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Birth
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
Birth
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
Birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Paul S Bernstein, MD, PhD, University of Utah Moran Eye Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2019

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

November 16, 2018

First Submitted That Met QC Criteria

November 20, 2018

First Posted (Actual)

November 23, 2018

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

June 17, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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