Evidence map›Paper›PMID 21706518›Full record

Trial reportJournal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research2011

Vitamin D supplementation during pregnancy: double-blind, randomized clinical trial of safety and effectiveness.

Bruce W Hollis, Donna Johnson, Thomas C Hulsey, Myla Ebeling, Carol L Wagner

Erratum issued 7 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 7 registered trials, which are not on this map. Cited by 357 papers, 19 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
357citing papers in PubMed, 19 pooled it
45.1field-weighted citation impact, top 1% 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.

NCT00292591 phase3completednot on this map

Evaluation of Vitamin D Requirements During Pregnancy

TypeinterventionalSponsorMedical University of South CarolinaRan2004 to 2010Enrolled501ConditionsVitamin D DeficiencyArmscholecalciferol (vitamin D3), cholecalciferol
NCT01932788 phase3completednot on this mapstarted 2013, after this paper: background citation

Preventing Health Disparities During Pregnancy Through Vitamin D Supplementation

TypeinterventionalSponsorMedical University of South CarolinaRan2013 to 2018Enrolled342ConditionsVitamin D3 DeficiencyArmsVitamin D3 4000 IU in gummy form, Placebo gummy vitamin
NCT02434380 phase3completednot on this mapstarted 2015, after this paper: background citation

Effect of Vitamin D Replacement on Maternal and Neonatal Outcomes: a Randomized Controlled Trial in Pregnant Women With Hypovitaminosis D

TypeinterventionalSponsorAmerican University of Beirut Medical CenterRan2015 to 2018Enrolled330ConditionsHypovitaminosis D, Pregnancy Complications, Infant, Newborn, DiseasesArmsEuro D
NCT02920593 phase4unknown statusnot on this mapstarted 2016, after this paper: background citation

A Randomized Control Trial of Vitamin D Prophylaxis in the Prevention of Hypertensive Disorders of Pregnancy

TypeinterventionalSponsorStony Brook UniversityRan2016 to 2019Enrolled412ConditionsGestational Hypertension, Toxemia, Superimposed Preeclampsia, EclampsiaArmsVitamin D3
NCT03087149 nacompletednot on this mapstarted 2017, after this paper: background citation

Supplementation of Vitamin D in Preterm Infants- Monitored Therapy vs Standard Therapy. A Randomized Controlled Trial

TypeinterventionalSponsorPrincess Anna Mazowiecka Hospital, Warsaw, PolandRan2017 to 2020Enrolled109ConditionsVitamin D Deficiency, Osteopenia, Nephrolithiasis, Drug OverdoseArmsmonitored vit D supplementation, standard vit D supplementation
NCT03645109 nacompletednot on this mapstarted 2020, after this paper: background citation

Effect of Suplementation of 5,000 UI Vitamin D3 on the Glycemic Profile in Patients With Gestational Diabetes Mellitus of the Hospital Civil de Guadalajara Dr. Juan I. Menchaca

TypeinterventionalSponsorEva Elizabet Camarena PulidoRan2020 to 2020Enrolled50ConditionsVitamin D3, Gestational Diabetes Mellitus in PregnancyArmsVitamin D3, Capsules with placebo (talcum food grade)
NCT06354621 phase1 / phase2completednot on this mapstarted 2023, after this paper: background citation

Impact of Vitamin D Supplementation on Fetomaternal Outcomes in Pregnant Females With Latent Tuberculosis Infection: A Randomized Controlled Trial in Lahore-Punjab

TypeinterventionalSponsorUniversity of the PunjabRan2023 to 2024Enrolled99ConditionsMaternal and Child HealthArmsVitamin-D supplementation
3 · Its place in the literature

Who cites it

357 citing papers in PubMed, 19 syntheses or guidelines pooled it, 839 citations in OpenAlex.

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  6. Vitamin D supplementation for women during pregnancy.The Cochrane database of systematic reviews · 2024
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  13. Maternal Dietary Factors and the Risk of Autism Spectrum Disorders: A Systematic Review of Existing Evidence.Autism research : official journal of the International Society for Autism Research · 2020
    Pooled it
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  15. Vitamin D supplementation for women during pregnancy.The Cochrane database of systematic reviews · 2019
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  20. Trial

297 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Bruce W HollisDivision of Neonatology and Department of Obstetrics and Gynecology, Medical University of South Carolina, Charleston, SC 29425, USA. hollisb@musc.edu
Donna Johnson
Thomas C Hulsey
Myla Ebeling
Carol L Wagner
Medical University of South Carolina · US

Funding

ZINC AND COPPER METABOLISM IN COLLAGEN DISORDERSM01RR001070 · NCRR · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI REVES, JOSEPH G · 1985 to 2009
$16.3M
SOUTH CAROLINA CLINICAL & TRANSLATIONAL RESEARCH INSTITUTE (SCTR)UL1RR029882 · NCRR · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BRADY, KATHLEEN T. · 2009 to 2011
$10.1M
Establishing the Vitamin D Requirements During LactationR01HD047511 · NICHD · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI HOLLIS, BRUCE W · 2006 to 2010
$2.8M
Evaluation of Vitamin D Requirements During PregnancyR01HD043921 · NICHD · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI HOLLIS, BRUCE W · 2003 to 2007
$2.6M
NCRR NIH HHS M01 RR001070NCRR NIH HHS RR01070NCRR NIH HHS UL1 RR029882NICHD NIH HHS R01 HD043921NICHD NIH HHS R01 HD047511NICHD NIH HHS R01 HD47511
6 · The paper itself

Abstract

The need, safety, and effectiveness of vitamin D supplementation during pregnancy remain controversial. In this randomized, controlled trial, women with a singleton pregnancy at 12 to 16 weeks' gestation received 400, 2000, or 4000 IU of vitamin D(3) per day until delivery. The primary outcome was maternal/neonatal circulating 25-hydroxyvitamin D [25(OH)D] concentration at delivery, with secondary outcomes of a 25(OH)D concentration of 80 nmol/L or greater achieved and the 25(OH)D concentration required to achieve maximal 1,25-dihydroxyvitamin D(3) [1,25(OH)(2)D(3)] production. Of the 494 women enrolled, 350 women continued until delivery: Mean 25(OH)D concentrations by group at delivery and 1 month before delivery were significantly different (p < 0.0001), and the percent who achieved sufficiency was significantly different by group, greatest in 4000-IU group (p < 0.0001). The relative risk (RR) for achieving a concentration of 80 nmol/L or greater within 1 month of delivery was significantly different between the 2000- and the 400-IU groups (RR = 1.52, 95% CI 1.24-1.86), the 4000- and the 400-IU groups (RR = 1.60, 95% CI 1.32-1.95) but not between the 4000- and. 2000-IU groups (RR = 1.06, 95% CI 0.93-1.19). Circulating 25(OH)D had a direct influence on circulating 1,25(OH)(2)D(3) concentrations throughout pregnancy (p < 0.0001), with maximal production of 1,25(OH)(2)D(3) in all strata in the 4000-IU group. There were no differences between groups on any safety measure. Not a single adverse event was attributed to vitamin D supplementation or circulating 25(OH)D levels. It is concluded that vitamin D supplementation of 4000 IU/d for pregnant women is safe and most effective in achieving sufficiency in all women and their neonates regardless of race, whereas the current estimated average requirement is comparatively ineffective at achieving adequate circulating 25(OH)D concentrations, especially in African Americans.

Indexed as

Dietary SupplementsDouble-Blind MethodFemaleHumansPregnancyVitamin DVitamin D

Identifiers

PMID21706518
PMCPMC3183324
OpenAlexW2132096646

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

and 1 more above

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.