Evidence map›Paper›PMID 31045798›Full record

ArticleMedicine2019

Effects of vitamin D supplementation on cardiovascular risk factors in shift workers: Study protocol for randomized, double-blind, placebo-controlled clinical trial.

Virginia Capistrano Fajardo, Fernando Luiz Pereira de Oliveira, George Luiz Lins Machado-Coelho, Fausto Aloísio Pedrosa Pimenta, Silvia Nascimento de Freitas, Antônio Luiz Pinho Ribeiro, Maria Marta Sarquis Soares, Marcio Weissheimer Lauria, Rosielle da Costa Farias, Ive Bahia França and 1 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.3field-weighted citation impact, top 41% 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

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Article
  3. 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

11 authors at 4 institutions in 2 countries.

Virginia Capistrano FajardoApplied Science to Adult Health Postgraduate Program, School of Medicine, Federal University of Minas Gerais, Belo Horizonte.
Fernando Luiz Pereira de OliveiraDepartment of Statistics, Institute of Exact and Biological Sciences.
George Luiz Lins Machado-CoelhoDepartment of Family Medicine, Mental and Collective Health, School of Medicine.
Fausto Aloísio Pedrosa PimentaDepartment of Pediatric and Adult Clinics, School of Medicine.
Silvia Nascimento de FreitasHealth and Nutrition Postgraduate Program, School of Nutrition, Federal University of Ouro Preto, Ouro Preto.
Antônio Luiz Pinho RibeiroDepartment of Clinical Medicine, School of Medicine, Federal University of Minas Gerais, Belo Horizonte.
Maria Marta Sarquis SoaresDepartment of Clinical Medicine, School of Medicine, Federal University of Minas Gerais, Belo Horizonte.
Marcio Weissheimer LauriaDepartment of Clinical Medicine, School of Medicine, Federal University of Minas Gerais, Belo Horizonte.
Rosielle da Costa FariasApplied Statistics and Biometrics Postgraduate Program, Department of Statistics, Federal University of Viçosa, Viçosa, MG.
Ive Bahia FrançaSchool of Medicine, University Center of Espirito Santo. Colatina, ES, Brazil.
Raimundo Marques do Nascimento NetoDepartment of Pediatric and Adult Clinics, School of Medicine.
Universidade Federal de Minas Gerais · BRAdult and Pediatric Dermatology · USUniversidade Federal de Ouro Preto · BRUniversidade Federal de Viçosa · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe present clinical study aims to describe protocol to evaluate the effects of vitamin D3 supplementation on the cardiovascular risk factors in a population of rotating shift workers.

designA randomized, double-blind, placebo-controlled, parallel group clinical trial testing 2 oral dosages of cholecalciferol (14,000 IU and 28,000 IU per week) for 12 months.

settingThe primary outcome for evaluation is an 18% reduction in hypertriglyceridemia (≥150 mg/dL) between pre and postintervention measurements. Baseline characteristics of the study population will be summarized separately within each randomized group, and will use tests for continuous and categorical variables. For all tests, a P < .05 will be considered significant. The analysis of primary and secondary outcomes will use an intention-to-treat population and a per-protocol population. The primary and secondary outcomes will be compared separately between each treatment group and placebo, using binary logistic regression or regressão de Poisson for proportions (for binary outcomes) and using linear regression for differences in means (for continuous endpoints), with 95% confidence intervals.

participantsRotating shift workers, adults aged between 18 and 60 years, with hypovitaminosis D and alterations in at least 1 of the following parameters: fasting glucose, high-density lipoprotein cholesterol, triglycerides, low-density lipoprotein cholesterol, blood pressure, and waist circumference.

conclusionThis clinical trial aims to contribute to the gap in knowledge about the potential, dose, and time of vitamin D supplementation to generate beneficial effects on triglycerides in a population at increased risk for hypertriglyceridemia and vitamin D deficiency.

Indexed as

Dietary SupplementsAdolescentAdultAge FactorsBlood GlucoseBlood PressureCardiovascular DiseasesCholecalciferolDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansLipidsMaleMiddle AgedRandomized Controlled Trials as TopicBlood GlucoseCholecalciferolLipidsreserpic acidReserpine

Identifiers

PMID31045798
PMCPMC6504534
OpenAlexW2942801193

What OpenQuestion 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 OpenQuestion graph.