Pulse Brain · Growing Health Evidence Index
Tier 2 — RCT, large cohort or strong causal designPeer-reviewed

The Lutein and Zeaxanthin in Pregnancy (L-ZIP) study—carotenoid supplementation during pregnancy: ocular and systemic effects—study protocol for a randomized controlled trial

Emmanuel Kofi Addo; Aruna Gorusupudi; Susan Allman; Paul S. Bernstein

Trials · 2021

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Summary

The L-ZIP trial is a double-masked, randomized controlled trial investigating whether prenatal maternal supplementation with 10 mg lutein and 2 mg zeaxanthin daily (via capsule in addition to standard prenatal vitamin) prevents carotenoid depletion during pregnancy and improves systemic and ocular carotenoid biomarkers in both mothers and infants. The study addresses a gap in evidence, as no prior prospective RCT has assessed carotenoid supplementation via prenatal vitamins and measured both maternal and infant ocular and systemic carotenoid status longitudinally across pregnancy.

Regional applicability

This study was conducted in the United States (University of Utah) and may have limited direct applicability to United Kingdom clinical practice, though the physiological mechanisms of carotenoid depletion during pregnancy and benefits for fetal retinal and brain development are likely to be universal. UK findings on the efficacy of carotenoid supplementation and optimal prenatal formulations could inform future guidance on micronutrient adequacy in UK prenatal care.

Key measures

Serum carotenoid levels (HPLC), skin carotenoid content (resonance Raman spectroscopy), macular pigment optical density, maternal and infant biomarkers of carotenoid status at baseline (first trimester), second trimester, third trimester, and 0–2 weeks postpartum

Outcomes reported

The study will measure maternal and infant serum, skin, and ocular carotenoid status (lutein, zeaxanthin, meso-zeaxanthin) across pregnancy trimesters and postpartum using resonance Raman spectroscopy, high-performance liquid chromatography, and macular pigment optical density assessment.

Theme
Nutrition & health
Subject
Maternal, infant & child nutrition
Study type
Research
Study design
RCT
Source type
Peer-reviewed study
Status
Published
Geography
United States
System type
Human clinical
DOI
10.1186/s13063-021-05244-2
Catalogue ID
NRmu5077j1-008

Topic tags

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