Abstract
Background
Depression, the leading cause of chronic disability worldwide, comprises an important cardiovascular risk factor, increasing the relative risk of coronary artery disease and cardiovascular morbidity and mortality. Concomitant with the higher prevalence of depression, there is also a reduction in exposure to sunlight, with increased urbanization and industrialization and the use of sunscreens leading to a decrease in serum levels of 25-hydroxyvitamin D. In this sense, this essay intends to evaluate the action supplementation with vitamin D in the management of depressive symptoms and cardiovascular risk factors, increasing the limited evidence on the potential effects of supplementation in situations related to mood regulation.
Methods
This is a randomized, double-blind, placebo-controlled clinical trial, built in accordance with SPIRIT, involving 224 adults aged 18-59 years with depression on antidepressants, no history of vitamin D supplementation, psychiatric comorbidities, chronic kidney disease, hypercalcemia, and neoplasms, attended at the psychiatric outpatient clinics of two universities in northeastern Brazil. Consent and eligible participants will be randomly assigned to the intervention groups (n = 112) who will receive vitamin D supplementation, 50,000 IU weekly for six months, and control (n = 112) who will use weekly placebo for six months. Measurements for the monitoring of depressive symptoms, clinical trials, and laboratory tests to assess cardiovascular risk factors and serum vitamin D levels will be performed at the beginning, during and after the intervention period.
Discussion
This is the first trial to test the efficacy of vitamin D supplementation in reducing cardiovascular risk and as adjuvant to antidepressant therapy over a long period (six months). The obtained results will support the understanding of the therapeutic effects of vitamin D supplementation in the management of mood disorders, as well as corroborate in the direction of public policies aimed at vitamin supplementation to prevent cardiovascular risk.
Vitamin D Supplementation in Chronic Schizophrenia Patients Treated with Clozapine: A Randomized, Double-Blind, Placebo-controlled Clinical Trial
