Evidence map›Paper›PMID 37247819›Full record

Trial reportThe Journal of nutrition2023

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.

Emmanuel K Addo, Susan J Allman, Ranganathan Arunkumar, Joanna E Gorka, Deborah Y Harrison, Michael W Varner, Paul S Bernstein

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of nutrition, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03750968 (Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03750968 phase2completednot on this map

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

TypeinterventionalSponsorPaul S. BernsteinRan2019 to 2022Enrolled47ConditionsNutrient Deficiency, Pregnancy RelatedArmsCarotenoid Group, Control Group
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Emmanuel K AddoDepartment of Ophthalmology and Visual Sciences, John A. Moran Eye Center, University of Utah School of Medicine, Salt Lake City, UT, USA; Department of Nutrition and Integrative Physiology, University of Utah, Salt Lake City, UT, USA.
Susan J AllmanDepartment of Ophthalmology and Visual Sciences, John A. Moran Eye Center, University of Utah School of Medicine, Salt Lake City, UT, USA.
Ranganathan ArunkumarDepartment of Ophthalmology and Visual Sciences, John A. Moran Eye Center, University of Utah School of Medicine, Salt Lake City, UT, USA.
Joanna E GorkaDepartment of Ophthalmology and Visual Sciences, John A. Moran Eye Center, University of Utah School of Medicine, Salt Lake City, UT, USA.
Deborah Y HarrisonDepartment of Ophthalmology and Visual Sciences, John A. Moran Eye Center, University of Utah School of Medicine, Salt Lake City, UT, USA.
Michael W VarnerDepartment of Obstetrics and Gynecology, University of Utah, Salt Lake City, UT, USA.
Paul S BernsteinDepartment of Ophthalmology and Visual Sciences, John A. Moran Eye Center, University of Utah School of Medicine, Salt Lake City, UT, USA; Department of Nutrition and Integrative Physiology, University of Utah, Salt Lake City, UT, USA. Electronic address: paul.bernstein@hsc.utah.edu.

Funding

University of Utah, Core Vision Research GrantP30EY014800 · NEI · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · PI Jun Yang · 2005 to 2026
$14.6M
Carotenoid Supplementation During Pregnancy: Ocular and Systemic EffectsR21EY029857 · NEI · UNIVERSITY OF UTAH · PI BERNSTEIN, PAUL STEVEN · 2019 to 2020
$419k
NEI NIH HHS P30 EY014800NEI NIH HHS R21 EY029857
6 · The paper itself

Abstract

backgroundAdding carotenoids, particularly lutein (L) and zeaxanthin (Z), to prenatal micronutrient formulations has been promoted to enhance infant visual and neural development and to maintain maternal health. Although these claims are biologically plausible, they are not yet supported by a compelling prospective trial.

objectiveWe investigated the effect of prenatal carotenoid supplementation on biomarkers of maternal and infant systemic carotenoid status.

methodsWe randomly assigned 47 first trimester pregnant subjects by 1:1 allocation to receive standard-of-care prenatal vitamins plus a 10 mg L and 2 mg Z softgel (the Carotenoid group) or standard-of-care prenatal vitamins with a placebo softgel (the Control group) for 6-8 mo. Maternal carotenoid concentrations in the serum and skin at the end of each trimester and postpartum were measured with HPLC and resonance Raman spectroscopy, respectively. Infants' systemic carotenoid status was assessed using similar techniques but optimized for infants. Repeated measures and paired t-tests were determined, and a P value < 0.05 was considered statistically significant.

resultsAfter supplementation, there was a statistically significant increase in maternal serum L + Z concentrations, serum total carotenoid concentrations, and skin carotenoid status (P < 0.001 for all) in the Carotenoid group relative to the Control group at all study time points. Similarly, infants whose mothers were in the Carotenoid group had a significant 5-fold increase in cord blood L + Z concentrations, over a 3-fold increase in cord blood total carotenoids, and a 38% increase in skin carotenoids compared with the Control group (P < 0.0001 for all). In addition, there was a strong positive, statistically significant correlation between postpartum maternal and infant systemic carotenoid status (P < 0.0001).

conclusionPrenatal carotenoid supplementation significantly increased maternal and infant systemic (skin and serum) carotenoid status, which may benefit pregnant women and their infants' health. This trial was registered at clinicaltrials.gov as NCT03750968.

Indexed as

LuteinMothersCarotenoidsDietary SupplementsFemaleHumansInfantPregnancyProspective StudiesVitaminsZeaxanthinsCarotenoidsLuteinVitaminsZeaxanthinsbiomarkersinfant carotenoid statuslutein and zeaxanthin in pregnancyprenatal carotenoid supplementationrandomized controlled trialsystemic effects

Identifiers

PMID37247819
PMCPMC10447612

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.