Evidence map›Paper›PMID 39173703›Full record

Trial reportFertility and sterility2025

Target trial emulation of preconception serum vitamin D status on fertility outcomes: a couples-based approach.

Julia D DiTosto, Ellen C Caniglia, Stefanie N Hinkle, Naria Sealy, Enrique F Schisterman, Erica Johnstone, Pauline Mendola, James Mills, Jim Hotaling, Ginny Ryan and 1 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Fertility and sterility, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01857310 (Folic Acid and Zinc Supplementation Trial), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT01857310 nacompletednot on this map

Folic Acid and Zinc Supplementation Trial: A Multi-center, Double-blind, Block-randomized, Placebo-controlled Trial

TypeinterventionalSponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Ran2013 to 2019Enrolled2,370ConditionsPregnancy, Live Birth, Spontaneous AbortionArms5 mg folic acid and 30 mg elemental zinc, Placebo Comparator: Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
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

11 authors.

Julia D DiTostoDepartment of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Ellen C CanigliaDepartment of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania; Department of Obstetrics and Gynecology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Stefanie N HinkleDepartment of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania; Department of Obstetrics and Gynecology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Naria SealyDepartment of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Enrique F SchistermanDepartment of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania; Department of Obstetrics and Gynecology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Erica JohnstoneDivision of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, University of Utah School of Medicine, Salt Lake City, Utah.
Pauline MendolaDepartment of Epidemiology and Environmental Health, School of Public Health and Health Professions, University at Buffalo, Buffalo, New York.
James MillsDivision of Intramural Population Health Research, Epidemiology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
Jim HotalingDepartment of Surgery (Urology) and Obstetrics and Gynecology, Center for Reconstructive Urology and Men's Health, University of Utah School of Medicine, Salt Lake City, Utah.
Ginny RyanDivision of Reproductive Endocrinology and Infertility, University of Washington School of Medicine, Seattle, Washington, D.C.
Sunni L MumfordDepartment of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania; Department of Obstetrics and Gynecology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: sunni.mumford@pennmedicine.upenn.edu.

Funding

Translational Research Support CoreP30ES013508 · NIEHS · UNIVERSITY OF PENNSYLVANIA · PI A. Clementina Mesaros · 2006 to 2026
$35.3M
Folic Acid and Zinc Supplementation TrialZIAHD008943 · NICHD · EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT · PI PERKINS, NEIL · 2014 to 2025
$5.0M
Impact of Diet, Exercise And Lifestyle on Fertility: The IDEAL Fertility StudyZIAHD008948 · NICHD · EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT · PI PERKINS, NEIL · 2015 to 2025
$1.7M
Intramural NIH HHS ZIA HD008943Intramural NIH HHS ZIA HD008948NICHD NIH HHS HHSN275201200007CNICHD NIH HHS HHSN275201300026INICHD NIH HHS HHSN275201500001CNIEHS NIH HHS P30 ES013508
6 · The paper itself

Abstract

objectiveTo evaluate associations between preconception 25-hydroxyvitamin D (25(OH)D) levels and biomarkers in female and male partners on live birth (LB), pregnancy loss, and semen quality.

designSecondary analysis using the folic acid and zinc supplementation trial of couples seeking infertility treatment at four US centers (2013-2017). A target trial emulation framework was applied to estimate associations. Couples were observed for 9 months or through pregnancy. SUBJECTS: Couples seeking infertility treatment. INTERVENTION(S): Preconception concentrations of 25(OH)D (primary) and associated biomarkers: vitamin D binding protein, calcium, free vitamin D, bioavailable vitamin D. MAIN OUTCOME MEASURE(S): Live birth and pregnancy loss were ascertained via self-report and medical records. Semen quality was ascertained 6 months after enrollment. Log-binomial regression estimated risk ratios and 95% confidence intervals (CIs). Individual and joint models and effect measure modification by preconception body mass index were considered. RESULT(S): Among 2,370 couples, 19.5% of females and 29.9% of males were 25(OH)D deficient. Females with sufficient status had a 28%-higher likelihood of LB than deficient females (95% CI, 1.05-1.56). Female and male 25(OH)D status were associated with LB among those with normal body mass index (sufficient vs. deficient: female adjusted risk ratio [aRR], 1.39; 95% CI, 1.00-1.99; male aRR, 1.51; 95% CI, 1.01-2.25) and among obese female partners (sufficient vs. deficient: aRR, 1.33; 95% CI, 0.95-1.85). Couples whose both partners had higher 25(OH)D status had increased likelihood of LB (both not deficient vs. both deficient aRR, 1.26; 95% CI, 1.00-1.58). No associations were observed with pregnancy loss or semen quality. Similar results were found for all biomarkers except calcium. CONCLUSION(S): Preconception vitamin D status and bioavailability impact fertility among couples seeking infertility therapy, likely unrelated to semen quality. Body mass index stratified analyses demonstrated heterogeneous associations. CLINICAL TRIAL REGISTRATION NUMBER: NCT01857310.

Indexed as

FertilityInfertilityPreconception CareVitamin DVitamin D DeficiencyAbortion, SpontaneousAdultBiomarkersFemaleHumansLive BirthMalePregnancyRisk FactorsSemen AnalysisUnited States25-hydroxyvitamin DBiomarkersVitamin DinfertilitylivebirthVitamin D

Identifiers

PMID39173703
PMCPMC11788044

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

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 Socratic graph.