Trial reportThe Journal of clinical investigation2016
Early pregnancy vitamin D status and risk of preeclampsia.
Trial report in The Journal of clinical investigation, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00920621 (Randomized Trial), which is not on this map. Cited by 101 papers, 8 of them syntheses that pooled it.
What it found
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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.
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.
Randomized Trial: Maternal Vitamin D Supplementation to Prevent Childhood Asthma (VDAART)
Who cites it
101 citing papers in PubMed, 8 syntheses or guidelines pooled it, 204 citations in OpenAlex.
- Comparative effectiveness of statins, metformin, and vitamin D, for prevention of preeclampsia: a systematic review and network meta-analysis of randomized trials.BMC pregnancy and childbirth · 2026Pooled it
- Vitamin D levels in early and middle pregnancy and preeclampsia: a systematic review and meta-analysis.Frontiers in medicine · 2025Pooled it
- Efficacy of vitamin D supplementation on the incidence of preeclampsia: a systematic review and meta-analysis.BMC pregnancy and childbirth · 2024Pooled it
- The Association Between Season and Hypertensive Disorders in Pregnancy: a Systematic Review and Meta-analysis.Reproductive sciences (Thousand Oaks, Calif.) · 2023Pooled it
- Vitamin D-Related Risk Factors for Maternal Morbidity during Pregnancy: A Systematic Review.Nutrients · 2022Pooled it
- Vitamin D Levels in Early and Middle Pregnancy and Preeclampsia, a Systematic Review and Meta-Analysis.Nutrients · 2022Pooled it
- The role of vitamin D in pre-eclampsia: a systematic review.BMC pregnancy and childbirth · 2017Pooled it
- Vitamin D supplementation higher than 2000 IU/day compared to lower dose on maternal-fetal outcome: Systematic review and meta-analysis.Women's health (London, England)Pooled it
- Higher Maternal Body Mass Index Attenuates the Response to High-Dose Vitamin D Supplementation During Pregnancy: A Secondary Analysis of the Randomized Vitamin D Antenatal Asthma Reduction Trial (VDAART).The Journal of nutrition · 2026Trial
- Exploring associations between maternal vitamin D-binding protein, vitamin D, and offspring asthma/recurrent wheeze.The American journal of clinical nutrition · 2026Trial
- Effects of multivitamin combined with magnesium sulfate versus magnesium sulfate alone on hemodynamics, coagulation, and maternal-infant outcomes in preeclampsia: a randomized controlled study.Journal of health, population, and nutrition · 2025Trial
- The association of early pregnancy vitamin D and BMI status with composite adverse pregnancy outcomes: an ancillary analysis of the Vitamin D Antenatal Asthma Reduction Trial.The American journal of clinical nutrition · 2025Trial
- Effect of early vitamin D supplementation on the incidence of preeclampsia in primigravid women: a randomised clinical trial in Eastern Democratic Republic of the Congo.BMC pregnancy and childbirth · 2024Trial
- Vitamin D and Child Neurodevelopment-A Post Hoc Analysis.Nutrients · 2023Trial
- Effect of early and late prenatal vitamin D and maternal asthma status on offspring asthma or recurrent wheeze.The Journal of allergy and clinical immunology · 2021Trial
- Effects of vitamin D supplementation on circulating concentrations of growth factors and immune-mediators in healthy women during pregnancy.Pediatric research · 2021Trial
- Vitamin D Sufficiency Has a Limited Effect on Placental Structure and Pathology: Placental Phenotypes in the VDAART Trial.Endocrinology · 2020Trial
- Transcriptome analysis of early pregnancy vitamin D status and spontaneous preterm birth.PloS one · 2020Trial
- Trial
- Vitamin D supplementation decreases immune activation and exhaustion in HIV-1-infected youth.Antiviral therapy · 2018Trial
41 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
23 authors at 6 institutions in 1 country.
Funding
Abstract
backgroundLow vitamin D status in pregnancy was proposed as a risk factor of preeclampsia.
methodsWe assessed the effect of vitamin D supplementation (4,400 vs. 400 IU/day), initiated early in pregnancy (10-18 weeks), on the development of preeclampsia. The effects of serum vitamin D (25-hydroxyvitamin D [25OHD]) levels on preeclampsia incidence at trial entry and in the third trimester (32-38 weeks) were studied. We also conducted a nested case-control study of 157 women to investigate peripheral blood vitamin D-associated gene expression profiles at 10 to 18 weeks in 47 participants who developed preeclampsia.
resultsOf 881 women randomized, outcome data were available for 816, with 67 (8.2%) developing preeclampsia. There was no significant difference between treatment (N = 408) or control (N = 408) groups in the incidence of preeclampsia (8.08% vs. 8.33%, respectively; relative risk: 0.97; 95% CI, 0.61-1.53). However, in a cohort analysis and after adjustment for confounders, a significant effect of sufficient vitamin D status (25OHD ≥30 ng/ml) was observed in both early and late pregnancy compared with insufficient levels (25OHD <30 ng/ml) (adjusted odds ratio, 0.28; 95% CI, 0.10-0.96). Differential expression of 348 vitamin D-associated genes (158 upregulated) was found in peripheral blood of women who developed preeclampsia (FDR <0.05 in the Vitamin D Antenatal Asthma Reduction Trial [VDAART]; P < 0.05 in a replication cohort). Functional enrichment and network analyses of this vitamin D-associated gene set suggests several highly functional modules related to systematic inflammatory and immune responses, including some nodes with a high degree of connectivity.
conclusionsVitamin D supplementation initiated in weeks 10-18 of pregnancy did not reduce preeclampsia incidence in the intention-to-treat paradigm. However, vitamin D levels of 30 ng/ml or higher at trial entry and in late pregnancy were associated with a lower risk of preeclampsia. Differentially expressed vitamin D-associated transcriptomes implicated the emergence of an early pregnancy, distinctive immune response in women who went on to develop preeclampsia.
trial registrationClinicalTrials.gov NCT00920621.
fundingQuebec Breast Cancer Foundation and Genome Canada Innovation Network. This trial was funded by the National Heart, Lung, and Blood Institute. For details see Acknowledgments.
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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.