Effects of Enteral Supplement Vitamin D Incritically Ill Patients
Primary Purpose
Vitamin D Deficiency, Critical Illness
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Vitamin D supplement
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Vitamin D Deficiency, critical Illness
Eligibility Criteria
Inclusion Criteria:
- patients in intensive care units
- blood calcifediol concentration less than 20 ng / mL
- suitable for enteral feeding
- no ileus, vomit, or diarrhea
Exclusion Criteria:
- younger than 20 years old
- receive high dose vitamin D within 4 weeks (> 3000 IU pre day)
- hypercalemia ( > 2.6 mmol/L)
- body weight < 45 or > 90 kg
- admitted to intensive care unit before this admission within 3 months
- have diseases as follows: parathyroid disease, rickets, or liver cirrhosis - Child C
- diagnosed with renal stone, tuberculosis, or sarcoidosis
- Non-native speaker
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Vitamin D
Arm Description
Enteral supplement of 569,600 IU vitamin D
Outcomes
Primary Outcome Measures
Vitmain D level
blood level of vitamin D
Secondary Outcome Measures
Vitmain D level
blood level of vitamin D
Full Information
NCT ID
NCT04292873
First Posted
March 1, 2020
Last Updated
March 22, 2022
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04292873
Brief Title
Effects of Enteral Supplement Vitamin D Incritically Ill Patients
Official Title
Investigating the Effects of Enteral Supplement of Vitamin D in Critically Ill Patients With Vitamin D Deficiency
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
At present, there is no clinical reference data on how much the concentration of calcifediol in the blood increases after supplementing with vitamin D for Taiwanese ICU patients. This study aims to investigate the effects of enteral supplementation of vitamin D in critically ill patients with vitamin D deficiency. The results of the study are expected to provide clinical reference data to intensivists to select adequate dosage of vitamin D supplementation for their patients with vitamin D deficiency.
This is a multi-center, randomized clinical trial. ICU patients will receive vitamin D level examination. If the subject's blood calcifediol concentration is less than 20 ng / mL, the subject will be included in this clinical trial. Patients who are suitable to enteral supplement of vitamin D will be randomly divided to group Control (no vitamin D supplement) and group Vitamin D (enteral supplement of 569,600 IU vitamin D). The vitamin D level will be measures at specific time points.
Detailed Description
Vitamin D deficiency patients have longer hospital stays, higher medical expenditures, and higher sepsis-related mortality. The preliminary results of 145 ICU patients of the Northern Medical Centers in Taiwan in our ongoing multicenter clinical trial showed that the mean calcifediol concentration was about 20.9 ng/mL, much lower than the normal value of 30-60 ng/ml. An Austrian randomized clinical trial has shown that supplementation of high-dose vitamin D in critically ill patients with vitamin D deficiency can reduce patient mortality, so it is important to treat critically ill patients with vitamin D deficiency. At present, there is no clinical reference data on how much the concentration of calcifediol in the blood increases after supplementing with vitamin D for Taiwanese ICU patients. This study aims to investigate the effects of enteral supplementation of vitamin D in critically ill patients with vitamin D deficiency. The results of the study are expected to provide clinical reference data to intensivists to select adequate dosage of vitamin D supplementation for their patients with vitamin D deficiency.
This is a multi-center, randomized clinical trial. ICU patients will receive vitamin D level examination. If the subject's blood calcifediol concentration is less than 20 ng / mL, the subject will be included in this clinical trial. Patients who are suitable to enteral supplement of vitamin D will be randomly divided to group Control (no vitamin D supplement) and group Vitamin D (enteral supplement of 569,600 IU vitamin D). The vitamin D level will be measures at specific time points. The patients' diagnosis, vital signs, laboratory data, 30-day survival, and 90-day survival will be recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Critical Illness
Keywords
Vitamin D Deficiency, critical Illness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
Enteral supplement of 569,600 IU vitamin D
Intervention Type
Other
Intervention Name(s)
Vitamin D supplement
Intervention Description
Enteral supplement of 569,600 IU vitamin D
Primary Outcome Measure Information:
Title
Vitmain D level
Description
blood level of vitamin D
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Vitmain D level
Description
blood level of vitamin D
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients in intensive care units
blood calcifediol concentration less than 20 ng / mL
suitable for enteral feeding
no ileus, vomit, or diarrhea
Exclusion Criteria:
younger than 20 years old
receive high dose vitamin D within 4 weeks (> 3000 IU pre day)
hypercalemia ( > 2.6 mmol/L)
body weight < 45 or > 90 kg
admitted to intensive care unit before this admission within 3 months
have diseases as follows: parathyroid disease, rickets, or liver cirrhosis - Child C
diagnosed with renal stone, tuberculosis, or sarcoidosis
Non-native speaker
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu-Chang Yeh, MD, PhD
Phone
+886-910513711
Email
tonyyeh@ntuh.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Chang Yeh, MD, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu-Chang Yeh, MD, PhD
Phone
+886-910513711
Email
tonyyeh@ntuh.gov.tw
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Enteral Supplement Vitamin D Incritically Ill Patients
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