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Emmanuel Kofi Addo, Aruna Gorusupudi, Susan Allman, Paul S Bernstein; The Lutein and Zeaxanthin in Pregnancy (L-ZIP) Trial – Initial Results. Invest. Ophthalmol. Vis. Sci. 2022;63(7):3374 – A0161.
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Recently, prenatal multivitamins with added lutein (L) and zeaxanthin (Z) have been introduced into the American market with claims of improving maternal and infants’ health. Although these claims are physiologically plausible, no evidence exists to support them. Hence, we conducted a prospective controlled trial (NCT03750968; still ongoing) to determine whether prenatal carotenoid supplementation counteracts maternal carotenoid depletion, particularly in the third trimester, and if it can enhance maternal and infants’ systemic and ocular carotenoid status.
In this trial, 47 participants were randomized 1:1 to receive standard-of-care daily prenatal vitamins with or without 10 mg of L and 2 mg of Z for 6 to 8 months. The primary outcome was maternal carotenoid status in the serum, skin, and eye measured at the end of each trimester and postpartum with HPLC, resonance Raman spectroscopy, and dual-wavelength autofluorescence, respectively. The secondary outcome assessed infants’ carotenoid levels in the umbilical cord blood, skin, and eyes using similar techniques as above but optimized for infants. Linear regression analysis was used to explore the association between maternal and infants’ carotenoid status. A p-value of 0.05 was considered statistically significant.
Participants’ mean (±SD) age was 29.7 (±3.7) years. Masked study analysis of all subjects shows a significant increase in maternal serum L+Z, skin carotenoids, and macular pigment optical density and volume at 9o eccentricity (MPOV9o) from the first trimester, a peak at the third trimester, and a decline postpartum. Postpartum maternal serum L+Z levels are significantly associated with umbilical cord blood L+Z levels (r=0.83, p<0.001) and infants’ skin carotenoids (r=0.66, p<0.001). There was a statistically significant positive correlation between postpartum maternal MPOV9o and cord blood L+Z levels (r=0.52, p=0.003) and infants’ skin carotenoids (r=0.48, p=0.007).
Unmasked study results will be available in early February 2022, and we will then know whether prenatal carotenoid supplementation prevents maternal carotenoid depletion and enhances infants’ foveal development. Our findings may serve as a basis for future large-scale research in normal and high-risk pregnancies and could guide policy decisions about prenatal carotenoid recommendations.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.
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