• Medicine · May 2019

    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, de OliveiraFernando Luiz PereiraFLPDepartment of Statistics, Institute of Exact and Biological Sciences., 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 Raimundo Marques do Nascimento Neto.
    • Applied Science to Adult Health Postgraduate Program, School of Medicine, Federal University of Minas Gerais, Belo Horizonte.
    • Medicine (Baltimore). 2019 May 1; 98 (18): e15417e15417.

    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.

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