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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04292873
Enrollment
61
Registered
2020-03-03
Start date
2020-03-16
Completion date
2023-03-31
Last updated
2023-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency, Critical Illness

Keywords

Vitamin D Deficiency, critical Illness

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.

Interventions

Enteral supplement of 569,600 IU vitamin D

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Vitmain D level7 daysblood level of vitamin D

Secondary

MeasureTime frameDescription
Vitmain D level14 daysblood level of vitamin D

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026