Evidence map›Paper›PMID 37510843›Full record

ArticleJournal of clinical medicine2023

Safety Profile of Vitamin D in Italy: An Analysis of Spontaneous Reports of Adverse Reactions Related to Drugs and Food Supplements.

Valentina Maggini, Giada Crescioli, Ilaria Ippoliti, Eugenia Gallo, Francesca Menniti-Ippolito, Adelaide Chiaravalloti, Vittorio Mascherini, Roberto Da Cas, Simona Potenza, Giulia Gritti and 5 more

Open access · goldAbstract read
In one paragraph

Article in Journal of clinical medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 26% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  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

15 authors at 4 institutions in 1 country.

Valentina MagginiResearch and Innovation Center in Phytotherapy and Integrated Medicine-CERFIT, Referring Center for Phytotherapy of Tuscany Region, Careggi University Hospital, 50141 Florence, Italy.ORCID 0000-0002-4227-7214
Giada CrescioliDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, 50141 Florence, Italy.ORCID 0000-0002-1071-6120
Ilaria IppolitiNational Centre for Drug Research and Evaluation, National Institute of Health, 00161 Rome, Italy.ORCID 0000-0001-5676-1595
Eugenia GalloResearch and Innovation Center in Phytotherapy and Integrated Medicine-CERFIT, Referring Center for Phytotherapy of Tuscany Region, Careggi University Hospital, 50141 Florence, Italy.
Francesca Menniti-IppolitoNational Centre for Drug Research and Evaluation, National Institute of Health, 00161 Rome, Italy.
Adelaide ChiaravallotiResearch and Innovation Center in Phytotherapy and Integrated Medicine-CERFIT, Referring Center for Phytotherapy of Tuscany Region, Careggi University Hospital, 50141 Florence, Italy.
Vittorio MascheriniResearch and Innovation Center in Phytotherapy and Integrated Medicine-CERFIT, Referring Center for Phytotherapy of Tuscany Region, Careggi University Hospital, 50141 Florence, Italy.
Roberto Da CasNational Centre for Drug Research and Evaluation, National Institute of Health, 00161 Rome, Italy.
Simona PotenzaItalian Medicines Agency, 00187 Rome, Italy.
Giulia GrittiItalian Medicines Agency, 00187 Rome, Italy.
Maria Teresa GaliuloItalian Medicines Agency, 00187 Rome, Italy.
Laura SottosantiItalian Medicines Agency, 00187 Rome, Italy.
Alfredo VannacciDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, 50141 Florence, Italy.ORCID 0000-0001-5259-2026
Niccolò LombardiDepartment of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, 50141 Florence, Italy.ORCID 0000-0002-9666-0438
Fabio FirenzuoliResearch and Innovation Center in Phytotherapy and Integrated Medicine-CERFIT, Referring Center for Phytotherapy of Tuscany Region, Careggi University Hospital, 50141 Florence, Italy.ORCID 0000-0003-1911-2021
Regione ToscanaItalian Medicines Agency · ITNational Centre for Disease Prevention and Control · ITUniversity of Florence · IT

Funding

Tuscany Region Resolution DGR 1118/2022
6 · The paper itself

Abstract

Vitamin D (VitD) is largely used in Italy, often inappropriately; thus, an evaluation of its safety is a crucial issue. This study analyses the adverse reactions (ARs) associated with the use of products containing VitD (VitDps) reported to the Italian National Pharmacovigilance and Phytovigilance networks. From March 2002 to August 2022, a total of 643 and 127 reports concerning 903 and 215 ARs were retrieved from Pharmacovigilance and Phytovigilance networks, respectively. Overall, 332 (29.6%) ARs were classified as serious, and the most described ones were hypercalcaemia, renal failure and tachycardia. Serious AR risk was significantly higher for subjects using more than four concomitant products (OR 2.44 [95% CI 1.30-4.60]) and VitD doses higher than 1000 IU/day (OR 2.70 [95% CI 1.30-5.64]). In Italy, there was a modest decrease in AR reporting, despite the slightly increased use of VitD during the COVID-19 pandemic. To the best of our knowledge, this is the first study describing all VitDps-related ARs observed in the Italian general population. Since underreporting is the main limitation of the safety reporting systems, the necessity to continue ARs monitoring, also using real-world data on VitDps prescription, use and outcome patterns is highlighted.

Indexed as

adverse reactionCOVID-19pharmacovigilancephytovigilancesafetyvitamin D

Identifiers

PMID37510843
PMCPMC10381134
OpenAlexW4384694778

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

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 Socratic graph.