At a glance
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Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects
In Brief
A Phase 2 clinical trial evaluating Carotenoid Group and Control Group for Nutrient Deficiency and Pregnancy Related. Completed, enrolled 47 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Softgel active ingredients: Lutein 10 mg and Zeaxanthin 2 mg in safflower oil
Placebo ingredients: Safflower oil