NCT04292873

Effects of Enteral Supplement Vitamin D Incritically Ill Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vitamin D Deficiency
• Critical Illness

Interventions

Type	Name	Description
OTHER	Vitamin D supplement	Enteral supplement of 569,600 IU vitamin D

Timeline

• Start date: 2020-03-16
• Primary completion: 2022-12-26
• Completion: 2023-03-31
• First posted: 2020-03-03
• Last updated: 2023-12-05

Locations

1 site across 1 country: Taiwan