Clinical trial NCT04292873: 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
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Critical Illness
Keywords: Vitamin D Deficiency, critical Illness
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 61
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Vitmain D level
timeFrame: 7 days
Secondary outcomes:
measure: Vitmain D level
timeFrame: 14 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yu-Chang Yeh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: