- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03639584
Prevalence of Deficiency of Vitamin D in Critically Ill Patients
Investigating the Prevalence of Deficiency of Vitamin D in Critically Ill Patients and Its Effects on the Prognosis
Visão geral do estudo
Status
Condições
Descrição detalhada
Studies have revealed that the serum level of 25-hydroxyvitamin D, as known as calcidiol, is low in critically ill patients. The prevalence ranges from 26 to 82%. 25-hydroxyvitamin D deficiency is associated with longer ICU stay, higher medical cost and higher death rate in septic patients. 25-hydroxyvitamin D is a kind of hormone related to bone and mineral metabolism. Moreover, the receptors were found in almost all cells, and it is related to immune system, cytokine release, cellular proliferation and differentiation, angiogenesis, and muscular energy. The main source is skin metabolism triggered by sunshine and food consumption. It is subsequently converted to calcifediol in the liver and then calcitriol in the kidney (the active form). Its serum level is regulated by parathyroid hormone and serum calcium and phosphate. The critically ill patients are deprived of sunshine, suffered from poor nutrition support, impaired liver and kidney function, higher rate of consumption, and are under higher risk of deficiency. Nowadays, the studies about 25-hydroxyvitamin D in ICU patients were conducted mostly in Europe and America. There is no large-scale study in Taiwan or Asia. A randomized controlled study from Austria has shown large dose supply in patients with 25-hydroxyvitamin D deficiency could decrease the mortality.
The object of this multi-center study is to investigate the prevalence of 25-hydroxyvitamin D deficiency, the risk factors and the correlation with outcomes. The results could be a step-stone for future randomized controlled studies.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- All ICU patients
Exclusion Criteria:
- 1, Less than 20 years 2, BMI < 18 kg/m^2 3, Had large dose vit D within previous four weeks (over 3000 IU per day) 4, ICU admission within previous three months 5, Have disease affecting vit D level, calcium metabolism, bone metabolism such as parathyroid disease, Rickets, liver cirrhosis child C 6, Communication difficulty
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Group 1
Patients admitted to ICU less than 48 hours and the anticipated stay is less than 5 days.
Take blood sample on the day of enrollment.
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Group 2
Patients admitted to ICU less than 48 hours and the anticipated stay is longer than 5 days.
Take blood sample on the day of enrollment, 7th, 14th, 21st, and 28th.
Stop blood sample once exit.
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Group 3
Patients admitted to ICU 3~7 days.
Take blood sample on the day of enrollment.
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Group 4
Patients admitted to ICU 8~14 days.
Take blood sample on the day of enrollment.
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Group 5
Patients admitted to ICU 15~28 days.
Take blood sample on the day of enrollment.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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The prevalence of Vitamin D deficiency
Prazo: 1 day at enrollment
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Investigate the prevalence of vitamin D deficiency among groups
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1 day at enrollment
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Difference of mortality on 28th and 90th day in group 2
Prazo: 90 days
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Compare the mortality of 28th and 90th day of patients with vitamin D deficiency and patients without vitamin D deficiency in group 2
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90 days
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Difference of mortality on 28th and 90th day in group 3, 4, and 5
Prazo: 90 days
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Compare the mortality of 28th and 90th day of patients with vitamin D deficiency and patients without vitamin D deficiency in group 3, 4, and 5
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90 days
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Serial changes of serum vitamin D levels in group 2
Prazo: 28 days
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investigate the serum vitamin D levels at different time points in group 2
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28 days
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Difference of 28-day ventialtor-free days
Prazo: 28 days
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Compare the 28-day ventialtor-free days of patients with vitamin D deficiency and patients without vitamin D deficiency for all groups
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28 days
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Difference of 28-day ICU-free days
Prazo: 28 days
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Compare the 28-day ICU-free days of patients with vitamin D deficiency and patients without vitamin D deficiency for all groups
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28 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Chung-Wei Chen, MD, Far Eastern Memorial Hospital
- Investigador principal: Li-Kuo Kuo, MD, Mackay Memorial Hospital
- Investigador principal: Kuo-Ching Yuan, MD, Taipei Medical University Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 201805087RINB
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