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

NCT03750968 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IRB # 116610
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nutrient Deficiency; Pregnancy Related

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• Infant Macular Carotenoid Levels as Determined by Macular Pigment Optical Density

  Birth

• Infant Serum Carotenoid Levels as Determined With High Performance Liquid Chromatography

  Birth

• Infant Skin Carotenoid Levels as Determined With Resonance Raman Spectroscopy

  Birth

Study Arms (2)

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.

Drug: Carotenoid Group

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.

Dietary Supplement: Control Group

Interventions

Carotenoid Group DRUG

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

Also known as: Softgel with lutein and zeaxanthin

Carotenoid group

Control Group DIETARY_SUPPLEMENT

Placebo ingredients: Safflower oil

Also known as: Softgel without lutein and zeaxanthin

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Paul S. Bernstein: lead

Study Sites (1)

University of Utah John A. Moran Eye Center

Salt Lake City, Utah, 84132, United States

Location

Related Publications (2)

• 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.

  PMID: 37247819 DERIVED

• 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.

  PMID: 33888136 DERIVED

MeSH Terms

Interventions

Lutein; Zeaxanthins; Control Groups

Intervention Hierarchy (Ancestors)

Xanthophylls; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Limitations and Caveats

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.

Results Point of Contact

• Title: Paul Bernstein, MD, PhD
• Organization: University of Utah John A. Moran Eye Center

Paul.Bernstein@hsc.utah.edu

801-581-4069

Study Officials

• Paul S Bernstein, MD, PhD

  University of Utah Moran Eye Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Ophthalmology/Visual Sciences

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 23, 2018
• Study Start: September 26, 2019
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: July 11, 2023
• Results First Posted: July 11, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)