Effects of Enteral Supplement Vitamin D Incritically Ill Patients

NCT ID: NCT04292873

Last Updated: 2023-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-16
• Study Completion Date: 2023-03-31

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.

Conditions

Vitamin D Deficiency; Critical Illness

Keywords

Vitamin D Deficiency, critical Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Vitamin D

Enteral supplement of 569,600 IU vitamin D

Group Type: EXPERIMENTAL

Vitamin D supplement

Intervention Type: OTHER

Enteral supplement of 569,600 IU vitamin D

Interventions

Vitamin D supplement

Enteral supplement of 569,600 IU vitamin D

Intervention Type: OTHER

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu-Chang Yeh, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

References

Wang AY, Yeh YC, Cheng KH, Han YY, Chiu CT, Chang CC, Wang IT, Chao A. Efficacy and safety of enteral supplementation with high-dose vitamin D in critically ill patients with vitamin D deficiency. J Formos Med Assoc. 2025 Apr;124(4):355-360. doi: 10.1016/j.jfma.2024.05.005. Epub 2024 May 10.

Reference Type: DERIVED

PMID: 38729818 (View on PubMed)

Other Identifiers

201902073MIPA

Identifier Type: -

Identifier Source: org_study_id