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NCT Number: NCT03639584

Prevalence of Deficiency of Vitamin D in Critically Ill Patients

Vitamin D has been shown to related to clinical outcomes in critically ill patients. The object of this study is to investigate the prevalence of Vitamin D deficiency in critically ill patients with various length of ICU stay .

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The prevalence of Vitamin D deficiency

    Time frame: 1 day at enrollment

    Investigate the prevalence of vitamin D deficiency among groups

Secondary outcomes

  1. Difference of mortality on 28th and 90th day in group 2

    Time frame: 90 days

    Compare the mortality of 28th and 90th day of patients with vitamin D deficiency and patients without vitamin D deficiency in group 2

  2. Difference of mortality on 28th and 90th day in group 3, 4, and 5

    Time frame: 90 days

    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

  3. Serial changes of serum vitamin D levels in group 2

    Time frame: 28 days

    investigate the serum vitamin D levels at different time points in group 2

  4. Difference of 28-day ventialtor-free days

    Time frame: 28 days

    Compare the 28-day ventialtor-free days of patients with vitamin D deficiency and patients without vitamin D deficiency for all groups

  5. Difference of 28-day ICU-free days

    Time frame: 28 days

    Compare the 28-day ICU-free days of patients with vitamin D deficiency and patients without vitamin D deficiency for all groups

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Investigating the Prevalence of Deficiency of Vitamin D in Critically Ill Patients and Its Effects on the Prognosis

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 21, 2018
Registry last updated
Apr 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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