Evidence map›Paper›PMID 31872219›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2020

Determinants and Measurement of Neonatal Vitamin D: Overestimation of 25(OH)D in Cord Blood Using CLIA Assay Technology.

Mengdi Lu, Bruce W Hollis, Vincent J Carey, Nancy Laranjo, Ravinder J Singh, Scott T Weiss, Augusto A Litonjua

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
1.4field-weighted citation impact, top 19% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 20 citations in OpenAlex.

  1. Vitamin D supplementation for women during pregnancy.The Cochrane database of systematic reviews · 2024
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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 at 4 institutions in 1 country.

Mengdi LuChanning Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Bruce W HollisDepartment of Pediatrics, University of South Carolina School of Medicine, Charleston, South Carolina.
Vincent J CareyChanning Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Nancy LaranjoChanning Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Ravinder J SinghDepartment of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.
Scott T WeissChanning Division of Network Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
Augusto A LitonjuaDepartment of Pediatrics, Golisano Children's Hospital at Strong, University of Rochester Medical Center, Rochester, New York.
Brigham and Women's Hospital · USMayo Clinic · USMedical University of South Carolina · USUniversity of Rochester Medical Center · US

Funding

VISUAL INDICES OF NEUROTOXICITYP30ES001247 · NIEHS · UNIVERSITY OF ROCHESTER · PI Martha Susiarjo · 1985 to 2026
$42.8M
SYSTEMS APPROACHES TO THE EPIDEMIOLOGY, GENETICS AND GENOMICS OF LUNG DISEASEST32HL007427 · NHLBI · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI DAWN L DEMEO, Edwin K Silverman · 1985 to 2026
$13.6M
Multi-omic approaches to mechanisms of vitamin D, environmental influences, and the microbiome on asthmaUH3OD023268 · OD · BRIGHAM AND WOMEN'S HOSPITAL · PI LITONJUA, AUGUSTO A, WEISS, SCOTT T · 2018 to 2022
$13.5M
Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood AsthmaU01HL091528 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI LITONJUA, AUGUSTO A, WEISS, SCOTT T · 2009 to 2013
$10.0M
RANDOMIZED CONTROLLED TRIAL: VDAART CONTINUATION STUDY - DCC - LEADR01HL091528 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI LITONJUA, AUGUSTO A, WEISS, SCOTT T · 2014 to 2018
$9.1M
NHLBI NIH HHS R01 HL091528NHLBI NIH HHS T32 HL007427NHLBI NIH HHS U01 HL091528NIEHS NIH HHS P30 ES001247NIH HHS UH3 OD023268
6 · The paper itself

Abstract

contextVitamin D (VD) deficiency in pregnancy and the neonatal period has impacts on childhood outcomes. Maternal VD sufficiency is crucial for sufficiency in the neonate, though the effect of early versus late pregnancy 25-hydroxy-vitamin D (25(OH)D) levels on neonatal levels is unknown. Furthermore, chemiluminescence immunoassays (CLIAs) are widely used, though their validity in measuring 25(OH)D specifically in cord blood specimens has not been established.

objectiveTo assess the validity of a CLIA in the measurement of cord blood 25(OH)D and to evaluate maternal determinants of neonatal 25(OH)D, including early versus late pregnancy 25(OH)D levels.

designThis is an ancillary analysis from the Vitamin D Antenatal Asthma Reduction Trial (VDAART), a randomized, double-blinded, placebo-controlled study. PARTICIPANTS AND

interventionA total of 881 pregnant women at high risk of having offspring asthma were randomized to receive VD supplementation or placebo. Serum samples were collected from mothers in early and late pregnancy and from offspring cord blood at birth. 25(OH)D levels were assayed by CLIA in all maternal and offspring samples and by LC-MS/MS in all offspring samples and a subset of 200 maternal third trimester samples.

resultsCord blood 25(OH)D levels were higher as measured by CLIA (mean 37.13 ng/mL [SD 18.30]) than by LC-MS/MS (mean 23.54 ng/mL [SD 11.99]), with a mean positive bias of 13.54 ng/mL (SD 12.92) by Bland-Altman analysis. This positive bias in measurement by CLIA was not observed in maternal samples. Third trimester 25(OH)D was a positive determinant of neonatal 25(OH)D levels.

conclusionChemiluminescence immunoassays overestimate 25(OH)D levels in human cord blood samples, an effect not observed in maternal blood samples. The quantification of 25(OH)D by CLIA should therefore not be considered valid when assayed in cord blood samples. Third trimester, but not first trimester, maternal 25(OH)D is one of several determinants of neonatal 25(OH)D status.

Indexed as

AdolescentAdultBiomarkersDouble-Blind MethodFemaleFetal BloodFollow-Up StudiesHumansImmunoassayInfant, NewbornPrognosisVitamin DVitamin D DeficiencyYoung Adult25-hydroxyvitamin DBiomarkersVitamin D25-hydroxy-vitamin Dneonatalpregnancyvitamin D

Identifiers

PMID31872219
PMCPMC7065842
OpenAlexW2998644516

What OpenQuestion holds

Textmetadata
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Registered trials

None linked

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.