Effects of Enteral Supplement Vitamin D Incritically Ill Patients

Critical Illness Clinical Trial

Official title:

Investigating the Effects of Enteral Supplement of Vitamin D in Critically Ill Patients With Vitamin D Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04292873
• Other study ID #: 201902073MIPA
• Status: Completed
• Phase: N/A
• Start date: March 16, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: December 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 31, 2023
• Est. primary completion date: December 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Vitamin D Deficiency

Intervention

Other:
• Vitamin D supplement
Enteral supplement of 569,600 IU vitamin D

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitmain D level	blood level of vitamin D	7 days
Secondary	Vitmain D level	blood level of vitamin D	14 days