Vitamin D and Critically Ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01636232
Recruitment Status : Completed
First Posted : July 10, 2012
Last Update Posted : June 6, 2016
Information provided by (Responsible Party):
Longxiang Su, Chinese PLA General Hospital

Brief Summary:
The higher rate of vitamin D deficiency is spotted among patients being hospitalized or in critical condition. Especially, vitamin D level below normal prolongs hospital stay and increases incidence of adverse prognosis and pushing up mortality of a number of diseases. However, it is remain unclear the relationship between vitamin D levels and critically ill, especially infection or sepsis. In this study, the investigators evaluate the significance of vitamin D for diagnosis and other relevant assessments of ICU cases, including vitamin D's relevance to sepsis, as well as its value in severity and prognosis assessment, high-performance liquid chromatography and tandem mass spectrometry was used to detect the quantification of the total 25(OH)D in serum of critically ill patients. The investigators speculate that measurement of vitamin D could be taken as an indicator for diagnosis and assessment in critically ill patients.

Condition or disease
Systemic Inflammatory Response Syndrome Sepsis

Study Type : Observational
Actual Enrollment : 234 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Vitamin D Levels and Risk of Infection, Assessment for Disease Severity, and Predictor of Mortality in the Chinese Intensive Care Units: a Prospective Cohort Study
Study Start Date : October 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Vitamin D
Drug Information available for: Vitamin D
U.S. FDA Resources

ICU sepsis group
The ICU sepsis group consisting of 105 critically-ill cases diagnosed with sepsis upon admission and sampled within the first 24h of their ICU stay.
ICU control group
the ICU control group including 51 critically-ill cases in whom sepsis was clinically excluded and from whom samples were taken upon admission.
healthy control group
the healthy control group composed of 50 healthy control outpatients. For the healthy control outpatients, possibilities of acute or past chronic diseases were excluded. Moreover, we made sure that the healthy control subjects had not been hospitalized or taken vitamin-based substitutive drugs in the last 12 months, and proved normal in physical checkups and lab examinations.

Primary Outcome Measures :
  1. Patients Outcome [ Time Frame: 28 days ]
    The survival time of patients more than 28 days is defined as survival. The survival time of patients less than 28 days is defined as death.

  2. Patients Outcome [ Time Frame: 90 days ]
    The survival time of patients more than 90 days is defined as survival. The survival time of patients less than 90 days is defined as death.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All the subjects were selected from among inpatients who were hospitalized between October-December, 2011 in the Surgical ICU, Respiratory ICU, and Emergency ICU, Chinese PLA General Hospital.

Inclusion Criteria:

  • Male and female aged 18 years old and over;
  • Entered ICU;
  • Fulfilled at least two criteria of systemic inflammatory response syndrome

    • core temperature higher than 38 °C or lower than 36 °C
    • respiratory rate above 20/min, or PCO2 below 32 mmHg
    • pulse rate above 90/min, and
    • white blood cell count greater than 12,000/μl or lower than < 4,000/μl or less than 10% of bands.

Exclusion Criteria:

  • patients or their relatives refused

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 identifier (NCT number): NCT01636232

Chinese PLA General Hospital
Beijing, China, 100853
Sponsors and Collaborators
Chinese PLA General Hospital
Study Director: Lixin Xie, MD Department Of Respiratory Diseases, Chinese PLA General Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Longxiang Su, Dr., Chinese PLA General Hospital Identifier: NCT01636232     History of Changes
Other Study ID Numbers: CPLAGH-2012026
First Posted: July 10, 2012    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: June 2016

Keywords provided by Longxiang Su, Chinese PLA General Hospital:
Vitamin D
disease severity
critically ill

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents