Effects of Early Vitamin D3 Supplementation on Clinical Outcomes for Critically Ill Patients

Critical Illness Clinical Trial

Official title:

Effects of Early Vitamin D3 Supplementation on Clinical Outcomes for Critically Ill Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05937789
• Other study ID #: 202305074RIPC
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2023
• Source: National Taiwan University Hospital
• Contact: Yin Yi Han, doctor
• Phone: 886972651405
• Email: noviahan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There are no clear international guidelines for dosing vitamin D based on deficiency severity. Therefore, a new clinical trial is needed to evaluate the benefits of early vitamin D supplementation in maintaining sufficient levels for critically ill patients. The investigators conducted a multicenter clinical trial in Taiwan focusing on vitamin D and critically ill patients. 240 patients with low calcidiol levels will be enrolled and be provided varying supplementation doses to maintain their serum calcidiol levels ≥ 30 ng/mL within 30 days of ICU admission. The results will serve as a valuable reference for intensivists when formulating appropriate vitamin D treatment strategy to maximize clinical benefits for critically ill patients.

Description:

Recent studies have highlighted a prevalent vitamin D deficiency in critically ill patients, ranging from 26% to 82%. These patients experience longer ICU stays, higher medical expenses, and increased sepsis-related mortality. The investigators conducted a multicenter clinical trial in Taiwan focusing on vitamin D and critically ill patients. In the first phase, the epidemiological investigation found significantly lower serum calcidiol levels of approximately 20.9 ng/mL compared to the normal range of 30-60 ng/mL in ICU patients. The second phase, a randomized control study, preliminarily demonstrated that supplementing 576,000 IU of vitamin D3 in critically ill patients with serum calcidiol levels below 20 ng/mL significantly reduced the risk of multidrug resistant bacterial infections within 30 days. An Austrian trial also showed that adequate vitamin D supplementation lowered in-hospital mortality in severely deficient patients. The importance of vitamin D supplementation for critically ill patients with vitamin D deficiency is evident, as their clinical prognosis is closely related to achieving adequate serum calcidiol levels. However, there are no clear international guidelines for dosing vitamin D based on deficiency severity. Therefore, a new clinical trial is needed to evaluate the benefits of early vitamin D supplementation in maintaining sufficient levels for critically ill patients. The investigators will enroll 240 patients with low calcidiol levels and provide varying supplementation doses to maintain their serum calcidiol levels ≥ 30 ng/mL within 30 days of ICU admission. The results will serve as a valuable reference for intensivists when formulating appropriate vitamin D treatment strategy to maximize clinical benefits for critically ill patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18-year-old critically ill patient.

• Admission to ICU < 24 hours.

• APACHE II at 24 hours of admission to ICU ranged from 20-39 points.

• The basic blood calcifediol concentration within 24 hours of admission to the intensive care unit is < 20 ng/mL.

• Intensive care physician expects patient to stay in ICU for = 72 hours.

Exclusion Criteria:

• Hypercalcemia (total calcium ion concentration in blood > 2.6 mmol/L).

• Disorders affecting serum calcifediol concentration, calcium metabolism, or bone metabolism (eg, parathyroid disease, rickets, or severe cirrhosis [Child C]).

• Have received high-dose vitamin D3 therapy (> 2000 IU per day or = 10,000 IU in a single dose) within four weeks.

• Admitted to the intensive care unit with a diagnosis of new coronary pneumonia (COVID-19).

• Organ transplant patients.

• Have had tuberculosis, sarcoidosis or kidney stones within a year.

• Kidney dialysis, continuous renal replacement therapy (Continuous Renal Replacement Therapy, CRRT), acute kidney injury (Acute kidney injury, AKI).

• Body weight <45 kg or >90 kg.

• Has been admitted to an intensive care unit within three months.

• Patients and family members who do not speak their native language.

• Pregnant women.

Related Conditions & MeSH terms

• Critical Illness
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D
One ampule of study sample contains 72,000 IU of vitamin D; Intervention starts on ICU day 3 with a frequency of 1 ampule every 3 hours and is completed within the following 48 hours
• Medium Chain Triglycerides (MCT)
One ampule of study sample contains 5 cc. of MCT; Intervention starts on ICU day 3 with a frequency of 1 ampule every 3 hours and is completed within the following 48 hours

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality within 30 days	Mortality within 30 days	30 days
Secondary	30-day mortality of patients who survived >7 days	30-day mortality of patients who survived >7 days	30 days
Secondary	Number of days that participants do not need to stay in the intensive care unit (ICU-free day) within 30 days	Number of days that participants do not need to stay in the intensive care unit (ICU-free day) within 30 days	30 days
Secondary	Number of days that surviving patients stayed in the ICU	Number of days that surviving patients stayed in the ICU	30 days
Secondary	Number of days of hospitalization for surviving patients	Number of days of hospitalization for surviving patients	30 days
Secondary	The difference in 30-day mortality between the two groups with serum calcifediol = 30 ng/mL and < 30 ng/mL on the seventh day of the treatment group.	The difference in 30-day mortality between the two groups with serum calcifediol = 30 ng/mL and < 30 ng/mL on the seventh day of the treatment group.	30 days
Secondary	The difference in 30-day mortality between the two groups with serum calcifediol = 30 ng/mL and < 30 ng/mL on day 30 of the treatment group.	The difference in 30-day mortality between the two groups with serum calcifediol = 30 ng/mL and < 30 ng/mL on day 30 of the treatment group.	30 days