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Prevalence of Deficiency of Vitamin D in Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT03639584
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
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 .

Condition or disease
Vitamin D Deficiency Critical Illness

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating the Prevalence of Deficiency of Vitamin D in Critically Ill Patients and Its Effects on the Prognosis
Actual Study Start Date : August 23, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Group/Cohort
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.
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.
Group 3
Patients admitted to ICU 3~7 days. Take blood sample on the day of enrollment.
Group 4
Patients admitted to ICU 8~14 days. Take blood sample on the day of enrollment.
Group 5
Patients admitted to ICU 15~28 days. Take blood sample on the day of enrollment.



Primary Outcome Measures :
  1. The prevalence of Vitamin D deficiency [ Time Frame: 1 day at enrollment ]
    Investigate the prevalence of vitamin D deficiency among groups


Secondary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
blood sample


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This is a multi-center, cross-sectional study involving four medical center in Taipei, Taiwan, which are National Taiwan University Hospital (NTUH), Far Eastern Memorial Hospital (FEMH), MacKay Memorial Hospital (MMH), and Taipei Medical University Hospital (TMUH). The target population is all the ICU patients, divided into four groups according to the length of ICU stay. The serum level of vit D, ICU event such as infection, ventilator dependency is to be recorded.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639584


Contacts
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Contact: Yu-Chang Yeh, MD, PhD 886-9-10513711 tonyyeh@ntuh.gov.tw
Contact: Kuo-Wei Chen, MD, MPH 886-2-23123456 duckgoway@gmail.com

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Yu-Chang Yeh, MD, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Chung-Wei Chen, MD Far Eastern Memorial Hospital
Principal Investigator: Li-Kuo Kuo, MD Mackay Memorial Hospital
Principal Investigator: Kuo-Ching Yuan, MD Taipei Medical University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03639584     History of Changes
Other Study ID Numbers: 201805087RINB
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Taiwan University Hospital:
Vitamin D Deficiency
Critical Illness

Additional relevant MeSH terms:
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Critical Illness
Vitamin D Deficiency
Disease Attributes
Pathologic Processes
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents