Skip to main content
OpenTrials
Completed

NCT Number: NCT04292873

Effects of Enteral Supplement Vitamin D Incritically Ill Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D supplement

Other

Enteral supplement of 569,600 IU vitamin D

Primary outcomes

  1. Vitmain D level

    Time frame: 7 days

    blood level of vitamin D

Secondary outcomes

  1. Vitmain D level

    Time frame: 14 days

    blood level of vitamin D

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Mar 3, 2020
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.