Bromelain and cardiovascular risk factors in diabetes: An exploratory randomized, placebo controlled, double blind clinical trial

Abstract Background: Depression is a major cause of chronic disability throughout the world and an important cardiovascular risk factor, increasing the relative risk of coronary artery disease as well as rates of cardiovascular morbidity and mortality. Concomitant to the greater prevalence of depression, there has been a reduction in exposure to sunlight with the increase in urbanization and the use of sun block, which has led to a reduction in serum levels of 25-hydroxyvitamin D. Therefore, this paper describes a protocol for a clinical trial aimed at evaluating the effects of vitamin D supplementation on depression and cardiovascular risk factors to contribute evidence regarding the potential influence of supplementation in situations related to mood regulation. Methods: This protocol study was guided by the SPIRIT recommendations. A randomized, placebo-controlled, double-blind trial will be conducted with 224 adults (age range: 18 to 59 years) with depression taking antidepressants with no history of vitamin D supplementation, psychiatric comorbidities, chronic kidney disease, hypercalcemia or neoplasm in care at psychiatric outpatient clinics of two universities in northeast Brazil. Eligible participants who provided written consent will be randomly designated to either the intervention group (n = 112; vitamin D supplementation – 50,000 IU per week for six months) or control group (n = 112; placebo taken weekly for six months). Measures for monitoring depressive symptoms, clinical trials and laboratory tests for evaluating cardiovascular risk factors and serum vitamin D levels will be performed before and after the intervention period. Discussion: To the best of our knowledge, this will be the first clinical trial with the aim of testing the effectiveness of vitamin D supplementation on the reduction in cardiovascular risk and as an adjuvant to depression therapy for a prolonged period (six months). The findings will contribute to the understanding of the therapeutic effects of vitamin D supplementation on the management of depression and can help guide public policies directed toward vitamin supplementation for the reduction of cardiovascular risk. Trial registration: Proof: http://www.ensaiosclinicos.gov.br/rg/. Number: RBR-6yj8sj / UTN Number: U1111-1217-9237 (July 23, 2018)

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Contributions of Vitamin D in the management of depressive symptoms and cardiovascular risk factors: study protocol for a randomized, double-blind, placebo-controlled clinical trial

10.21203/rs.2.383/v1 ◽

2019 ◽

Author(s):

Catarina Magalhaes Porto ◽

Tatiana de Paula Santana da Silva ◽

Everton Botelho Sougey

Keyword(s):

Risk Factors ◽

Clinical Trial ◽

Vitamin D ◽

Depressive Symptoms ◽

Cardiovascular Risk ◽

Cardiovascular Risk Factors ◽

Vitamin D Supplementation ◽

Controlled Clinical Trial ◽

Double Blind ◽

Double Blind Placebo

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.

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Contributions of Vitamin D in the management of depressive symptoms and cardiovascular risk factors: study protocol for a randomized, double-blind, placebo-controlled clinical trial

10.21203/rs.2.383/v2 ◽

2019 ◽

Author(s):

Catarina Magalhaes Porto ◽

Tatiana de Paula Santana da Silva ◽

Everton Botelho Sougey

Keyword(s):

Risk Factors ◽

Clinical Trial ◽

Vitamin D ◽

Depressive Symptoms ◽

Cardiovascular Risk ◽

Cardiovascular Risk Factors ◽

Vitamin D Supplementation ◽

Therapeutic Effects ◽

Double Blind ◽

Cardiovascular Morbidity And Mortality

Abstract Background: Depression is a major cause of chronic disability throughout the world and an important cardiovascular risk factor, increasing the relative risk of coronary artery disease as well as rates of cardiovascular morbidity and mortality. Concomitant to the greater prevalence of depression, there has been a reduction in exposure to sunlight with the increase in urbanization and the use of sun block, which has led to a reduction in serum levels of 25-hydroxyvitamin D. Therefore, this paper describes a protocol for a clinical trial aimed at evaluating the effects of vitamin D supplementation on depression and cardiovascular risk factors to contribute evidence regarding the potential influence of supplementation in situations related to mood regulation. Methods: This protocol study was guided by the SPIRIT recommendations. A randomized, placebo-controlled, double-blind trial will be conducted with 224 adults (age range: 18 to 59 years) with depression taking antidepressants with no history of vitamin D supplementation, psychiatric comorbidities, chronic kidney disease, hypercalcemia or neoplasm in care at psychiatric outpatient clinics of two universities in northeast Brazil. Eligible participants who provided written consent will be randomly designated to either the intervention group (n = 112; vitamin D supplementation – 50,000 IU per week for six months) or control group (n = 112; placebo taken weekly for six months). Measures for monitoring depressive symptoms, clinical trials and laboratory tests for evaluating cardiovascular risk factors and serum vitamin D levels will be performed before and after the intervention period. Discussion: To the best of our knowledge, this will be the first clinical trial with the aim of testing the effectiveness of vitamin D supplementation on the reduction in cardiovascular risk and as an adjuvant to depression therapy for a prolonged period (six months). The findings will contribute to the understanding of the therapeutic effects of vitamin D supplementation on the management of depression and can help guide public policies directed toward vitamin supplementation for the reduction of cardiovascular risk. Trial registration: Proof: http://www.ensaiosclinicos.gov.br/rg/. Number: RBR-6yj8sj / UTN Number: U1111-1217-9237 (July 23, 2018)

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Contributions of Vitamin D in the management of depressive symptoms and cardiovascular risk factors: study protocol for a randomized, double-blind, placebo-controlled clinical trial

10.21203/rs.2.383/v3 ◽

2019 ◽

Author(s):

Catarina Magalhaes Porto ◽

Tatiana de Paula Santana da Silva ◽

Everton Botelho Sougey

Keyword(s):

Risk Factors ◽

Clinical Trial ◽

Vitamin D ◽

Depressive Symptoms ◽

Cardiovascular Risk ◽

Cardiovascular Risk Factors ◽

Vitamin D Supplementation ◽

Therapeutic Effects ◽

Double Blind ◽

Cardiovascular Morbidity And Mortality

Abstract Background: Depression is a major cause of chronic disability throughout the world and an important cardiovascular risk factor, increasing the relative risk of coronary artery disease as well as rates of cardiovascular morbidity and mortality. Concomitant to the greater prevalence of depression, there has been a reduction in exposure to sunlight with the increase in urbanization and the use of sun block, which has led to a reduction in serum levels of 25-hydroxyvitamin D. Therefore, this paper describes a protocol for a clinical trial aimed at evaluating the effects of vitamin D supplementation on depression and cardiovascular risk factors to contribute evidence regarding the potential influence of supplementation in situations related to mood regulation. Methods: This protocol study was guided by the SPIRIT recommendations. A randomized, placebo-controlled, double-blind trial will be conducted with 224 adults (age range: 18 to 59 years) with depression taking antidepressants with no history of vitamin D supplementation, psychiatric comorbidities, chronic kidney disease, hypercalcemia or neoplasm in care at psychiatric outpatient clinics of two universities in northeast Brazil. Eligible participants who provided written consent will be randomly designated to either the intervention group (n = 112; vitamin D supplementation – 50,000 IU per week for six months) or control group (n = 112; placebo taken weekly for six months). Measures for monitoring depressive symptoms, clinical trials and laboratory tests for evaluating cardiovascular risk factors and serum vitamin D levels will be performed before and after the intervention period. Discussion: To the best of our knowledge, this will be the first clinical trial with the aim of testing the effectiveness of vitamin D supplementation on the reduction in cardiovascular risk and as an adjuvant to depression therapy for a prolonged period (six months). The findings will contribute to the understanding of the therapeutic effects of vitamin D supplementation on the management of depression and can help guide public policies directed toward vitamin supplementation for the reduction of cardiovascular risk. Trial registration: Proof: http://www.ensaiosclinicos.gov.br/rg/. Number: RBR-6yj8sj / UTN Number: U1111-1217-9237 (July 23, 2018)

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