Actively Recruiting
Early Vitamin D3 Supplementation for Critically Ill Patients
Led by National Taiwan University Hospital · Updated on 2024-08-16
240
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 serum levels of calcidiol and PTH will be measured on Day 0, Day 7, Day 14 and Day 30 before and after vitamin D supplementation. 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.
CONDITIONS
Official Title
Early Vitamin D3 Supplementation for Critically Ill Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Critically ill patients aged 18 years or older
- ICU admission less than 24 hours ago
- Vitamin D levels below 20 ng/mL within 24 hours of ICU admission
- Expected ICU stay of 72 hours or more
You will not qualify if you...
- High blood calcium levels (total serum calcium above 2.6 mmol/L)
- Disorders affecting vitamin D, calcium, or bone metabolism such as parathyroid disease, rickets, or severe liver cirrhosis (Child C)
- Received high-dose vitamin D3 therapy (more than 2,000 IU daily or a single dose of 10,000 IU or more) in the past 4 weeks
- Active COVID-19 infection at ICU admission
- History of organ transplant
- Tuberculosis, sarcoidosis, or kidney stones within the past year
- Current renal dialysis, continuous kidney replacement therapy, or acute kidney injury
- ICU admission within the past 3 months
- Non-native-speaking patients and their families
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
Research Team
Y
Yin Yi Han, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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