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

• Status: Active, not recruiting
• Trial end date: 2022-08-31
• Target enrollment: 0
• Participant gender: Female

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 6.0 milligrams of lutein and 0.5 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Paul S. Bernstein
• Treatments: Carotenoids

Criteria

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