Effects of Enteral Supplement Vitamin D Incritically Ill Patients

NCT04292873 | Completed

• 1 other identifier: 201902073MIPA
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency; Critical Illness

Keywords

Vitamin D Deficiency, critical Illness

Outcome Measures

Primary Outcomes (1)

• Vitmain D level

  blood level of vitamin D

  7 days

Secondary Outcomes (1)

• Vitmain D level

  14 days

Study Arms (2)

Control

NO INTERVENTION

Vitamin D

EXPERIMENTAL

Enteral supplement of 569,600 IU vitamin D

Other: Vitamin D supplement

Interventions

Vitamin D supplement OTHER

Enteral supplement of 569,600 IU vitamin D

Vitamin D

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients in intensive care units
• blood calcifediol concentration less than 20 ng / mL
• suitable for enteral feeding
• no ileus, vomit, or diarrhea

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 38729818 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency; Critical Illness

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yu-Chang Yeh, MD, PhD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2020
• First Posted: March 3, 2020
• Study Start: March 16, 2020
• Primary Completion: December 26, 2022
• Study Completion: March 31, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)